ISO/TR 24290:2023

© ISO 2023 – All rights reserved
ISO/DTR 24290.2:2023(E)
Date: 2023-02-07
ISO/TC 215/WG 2
Date: YYYY-MM-DD
Secretariat: ANSI
Health Informaticsinformatics — Datasets and data structure for
clinical and biological evaluation metrics in radiotherapy

DTR ballot

---------------------- Page: 1 ----------------------
ISO/DTR 24290:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of
this publication may be reproduced or utilized otherwise in any form or by any means, electronic or
mechanical, including photocopying, or posting on the internet or an intranet, without prior written
permission. Permission can be requested from either ISO at the address below or ISO’s member body in the
country of the requester.
ISO Copyright Office
CP 401 • CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DTR 24290:2023(E)
Contents
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 4
5 CBENs in EBRT . 5
5.1 General . 5
5.2 CBEMs. 5
5.3 Use case of CBEMs . 6
5.3.1 Selection of the EBRT modality . 6
5.3.2 Clinical trials . 7
5.4 Existing data format for CBEMs . 8
6 Datasets and data structure for a CBEM . 8
6.1 General . 8
6.2 Datasets and data structure . 8
6.2.1 Structure of the CBEM report . 8
6.2.2 Structure of the body part . 8
6.2.3 Patient condition information . 9
6.2.4 Treatment plan information. 9
6.2.5 CBEM information . 10
6.2.6 Comments on CBEM report . 11
Annex A (informative) Example of a CBEM model and related data elements . 12
Bibliography . 14


© ISO 2023 – All rights reserved iii

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ISO/DTR 24290:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC215TC 215, Health Informaticsinformatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv © ISO 2023 – All rights reserved

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ISO/DTR 24290:2023(E)
Introduction
Radiotherapy or radiation therapy is a treatment method used mostly in cancer care. Due to rapid
technical advances of the radiotherapy treatment modalities, it is becoming increasingly important to
select an appropriate radiotherapy treatment modality for individual patients by considering patient
conditions and the resources that are required.
In the case of external-beam radiation therapy (EBRT), where the therapeutic radiation beams are
emitted from a machine outside the body of the patient, treatment planning is performed prior to
treatment. When selecting a treatment modality from among possible candidates, treatment plans are
made for the candidates, if necessary, and then the dosimetric indices and/or radiobiological metrics
corresponding to the treatment plans are compared.
Tumour control probability (TCP), and normal tissue complication probability (NTCP) are among the
metrics used in the comparisons. They are simple phenomenological models based on clinical
[12]
observations which are described in the ICRU83 report[14]ICRU 83 as clinical and biological
evaluation metrics (CBEMCBEMs), along with other metrics such as equivalent uniform dose, conformity
and homogeneity indices, and so on. Recently, more sophisticated models incorporating non-dosimetric
patient factors, spatial dose metrics, and -omics elements (e.g.,. radiomics and proteomics), have also
received attention and some of them are starting to be referred to in clinical trials in some countries.
For wider and safer use of CBEMCBEMs in clinical practice and clinical trials, it will beis important to
provide an effective framework for ensuring the traceability of calculated metrics. Standardization of data
formats for reporting calculated CBEMCBEMs is one possible way. However, no attention has been paid
to such standardization to date, while there is active research on new metrics or new models as well as
increasing attention to transparent reporting of developed models.
This document describes datasets and data structure for the reporting of CBEMCBEMs, especially of
simple model types of TCP and NTCP. Scientific aspects of reliability of CBEMCBEMs are not in the scope
of this document. Because of the variety of CBEM models, when an evaluated CBEM is to be reported
and/or referred to, it is important to report and/or refer to the value of the calculated CBEM along with
information about the CBEM model itself as well as with dose information and non-dosimetric factors of
the patient that are used in the calculation. It is also important to include descriptions about uncertainties,
underlying assumptions, limitations, and situations for application of the CBEM model. In general, the
dose information of the treatment plan used in the calculations, (dose-volume histogram (DVH) in most
cases,) is converted to match the model definition,; for instance, adjusting the differences in fraction size
between the plan of the patient and the reference fraction size of the CBEM model. This means that the
apparent values of the doses (e.g.,. maximum dose and mean dose) used in the calculation are to be CBEM-
model-specific. To ensure traceability, inclusion of the description about the process of such dose
conversions along with the value of the representative dose values would be a great help. This document
provides datasets and data structure for CBEM reporting by considering the above mentioned aspects.
While this document is not intended to cover the reporting of CBEMCBEMs by contemporary
sophisticated models, the data structures described in this document can provide good guidance for apply
to the reporting of them as well.
© ISO 2023 – All rights reserved v

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DRAFT TECHNICAL REPORT ISO/DTR 24290:2023(E)

Health Informaticsinformatics — Datasets and data structure for
clinical and biological evaluation metrics in radiotherapy
1 Scope
The scope of thisThis document is the reporting of reports on the datasets and a data structure for
reporting clinical and biological evaluation metrics (CBEMs). Reporting The reporting of radiation dose
estimates is outside the scope of this document.
This document covers is applicable to CBEMs for external-beam radiation therapy (EBRT) modalities
(EBRT), but not CBEMs for brachytherapy or molecular radiotherapy.
Various types of radiotherapy treatment modalities are available for cancer care. Consequently, there is
a growing awareness of the need for objective schemes that will contribute to enable the selection of an
appropriate radiotherapy treatment modality for individual patients. The use of clinical and biological
evaluation metrics (CBEM)CBEMs, the metrics associated with a certain radiotherapy treatment plan for
a patient, is attracting attention for clinical purposes in the field of external-beam radiation therapy
(EBRT). In anticipation of the clinical use of CBEMCBEMs, the importance of research on clinical and
scientific aspects of the CBEMCBEMs is increasing, in concert with the importance of establishing a
standardized data format for reporting of specifics of a CBEM. This document illustrates datasets and a
data structure for reporting CBEM.
The scope of this document is the reporting of CBEM. Reporting of radiation dose estimates is outside the
scope of this document. This document covers CBEM for external-beam radiation therapy modalities
(EBRT), but not CBEM for brachytherapy or molecular radiotherapy.
32 Normative references
There are no normative references in this document.
43 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
computed tomography
CT
radiographic scanning technique that uses a number of CT projections of an object at different angles in
order to allow calculation of a CT image
[SOURCE: ISO 15708-1:2017, 3.7]
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ISO/DTR 24290:2023(E)
3.23.1
data element
DE
unit of data that is considered in context to be indivisible
[SOURCE:ISO/IEC 15944-1:2011, 3.16]
Note 1 to entry: The definition states that a data element is “indivisible” in some context. This means it is possible
that a data element considered indivisible in one context (e.g.,. telephone number) maycan be divisible in another
context (e.g.,. country code, area code, local number). [SOURCE: ISO/IEC 11179-1:2015, 3.3.8]
[SOURCE: ISO/IEC 11179-1:2023, 3.3.4, modified — Example deleted.]
3.2
3.3
Digital Imaging and Communications in Medicine
DICOM
standard for the communication and management of medical imaging information and related data
Note 1 to entry: The DICOM Standard facilitates interoperability of medical imaging equipment.
Note 2 to entry: DICOM is defined in ISO 12052.
[SOURCE: ISO/IEC 39794-16:2021, 3.16]
3.43
dose fractionation
method of administration of radiation in which the absorbed dose is divided into two or more fractions
separated in time
[SOURCE: IEV ref 881-11-18]
3.54
dose-volume histogram
DVH
dose as a distribution-function or frequency-function over a specified volume
[SOURCE: ICRU 50, modified — Abbreviated term “DVH” added.]
3.65
endpoint
principal indicator(s) used for providing the evidence for clinical performance, effectiveness
or safety in a clinical investigation
[SOURCE: ISO 14155:2020, 3.22]
3.76
intensity-modulated radiation therapy
IMRT
treatment procedure requiring, in general, the coordinated control of photon or electron fluence, beam
orientation relative to the patient, and beam size of the external beam, either in a continuous or a discrete
manner, and as pre-determined by a treatment plan (3.12)
Note 1 to entry: The primary purpose of IMRT is to improve the conformity of the dose distribution to the planned
target volume, while minimizing dose to surrounding healthy tissue.
2 © ISO 2023 – All rights reserved

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ISO/DTR 24290:2023(E)
[SOURCE: IEC 60976:2016, 3.2.7]
3.8
LOINC
Logical Observation Identifiers Names and Codes (Regenstrief Institute, Inc.)
[SOURCE: ISO 11240:2012, 3.2.3]
3.98
numerical value equation
numerical quantity value equation
mathematical relation between numerical quantity values, based on a given quantity equation and
specified measurement units
[SOURCE: ISO/IEC Guide 99:2007, 1.25, modified examples removed— Examples deleted.]
3.108
radiotherapy
radiation therapy
therapy that uses ionizing radiation to kill cells and shrink pathological tissues
Note 1 to entry: Radiation may be delivered by a machine outside the body (external-beam radiation therapy), or it
may come from radioactive material placed in the body near cancer cells (brachytherapy) or from
radiopharmaceutical administered to the patient (molecular radiotherapy).
[SOURCE: ISO 12749-6:2020, 3.3.2]
3.119
radiotherapy treatment planning system
RTPS
device, usually a programmable electrical medical system including its associated peripherals, that is
used to simulate the application of radiation to a patient for a proposed radiotherapy treatment
Note 1 to entry: It usually, but not necessarily, provides estimations of absorbed dose distribution in human tissue
using a particular algorithm or algorithms. These algorithms provide simulations of radiation that is typically from,
but not necessarily limited to, medical electron accelerators, gamma beam therapy equipment, or in brachytherapy
from radioactive sources.
[SOURCE: IEC 62083, ed. 2.0 (:2009-09), 3.1.6]
3.1210
region of interest
ROI
sub-dataset picked out from the entire dataset for a specific purpose
[SOURCE: ISO 20263:2017(, 3.1.24]
3.1311
relative biological effectiveness (of radiation)
RBE
ratio of the absorbed dose of a reference radiation to the absorbed dose of the radiation of
interest, generally X-ray or gamma ray, that produces the same level of biological effect
Note 1 to entry: The term should only be used in radiobiology.
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ISO/DTR 24290:2023(E)
[SOURCE: IEV ref 881-17-03]
3.1412
treatment plan
all patient and dosimetric information that is intended for use by appropriately qualified persons for the
purpose of prescribing or administering radiotherapy (3.8), including any information to be transmitted
to other equipment
Note 1 to entry: A printed or plotted treatment plan is referred to as a treatment plan report.
[SOURCE: IEC 62083, ed. 2.0 (:2009-09), 3.1.8]
3.1513
treatment planning
process of establishing the treatment plan (3.12)
[SOURCE: IEC 62083, ed. 2.0 (:2009-09), 3.1.9]
54 Abbreviated terms
This list of abbreviated terms includes all abbreviations used in this document.
CBEM Clinical and Biological Evaluation Metricclinical and biological evaluation metric
CI Confidence Intervalconfidence interval
DICOM Digital Imaging and Communications in Medicine
DVH Dose-Volume Histogramdose-volume histogram
EBRT External-Beam Radiation Therapyexternal-beam radiation therapy
IMRT intensity-modulated radiation therapy
LOINC Logical Observation Identifiers Names and Codes (Regenstrief Institute, Inc.)
NTCP Normal Tissue Complication Probabilitynormal tissue complication probability
RBE relative biological effectiveness
ROI region of interest
RTPS radiotherapy treatment planning system
TCP Tumor Control Probabilitytumour control probability
4 © ISO 2023 – All rights reserved

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ISO/DTR 24290:2023(E)
65 CBENs in external-beam radiation therapy (EBRT)
6.15.1 General
EBRT is a form of radiotherapy for delivering a beam or beams of ionizing radiation from outside the
body of patients. There are several different types of modalities of EBRT (EBRT modality) regarding beam
types and ways of forming dose distributions in the patient body, each provided by a specific device or
system. For specific patients, a suitable EBRT modality is selected among those available by considering
the patient condition and the resources required. Recently, the use of clinical and biological evaluation
metrics (CBEM)CBEMs for treatment plans of EBRT has been gaining attention in clinical practice and for
research purposes.
6.25.2 CBEMs
[ 12]
In ICRU 83 14 , the concept of CBEM is described in the section of “Level 3 Reporting” for intensity-
modulated radiation therapy (IMRT). IMRT is one EBRT modality, however, the described concept of the
[12]
CBEM can also be applicable to other EBRT modalities. In ICRU 83 , TCP, NTCP, and combination
metrics of TCP and NTCP are described. This present technical report coversdocument examines TCP and
NTCP as CBEM,CBEMs but does not coverexamine combination metrics of these two.
The CBEM is a metric which is associated with a treatment plan. Multiple CBEMs can be associated with
one treatment plan, for examplee.g. on metrics for different endpoints and/or by different CBEM models.

Figure 1 – Schematic of the CBEM calculation process
A schematic figure of the calculation process of a CBEM is shown in Figure 1. A CBEM is calculated using
a CBEM model which is expressed as one or multiple numerical value equations. The input to the
equations is the radiation dose information of a region of interest (ROI) for a treatment plan, which
corresponds to the definition of the CBEM model. In particular cases, it can be multiple ROIs. If the model
requires information regarding patient factors, this is also input for the calculations.

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ISO/DTR 24290:2023(E)
Figure 1 — Schematic of the CBEM calculation process
When the type of a CBEM is TCP, the ROI is the tissue volume that contains the tumour to be treated,
depending on the definition of the TCP model. When the type of a CBEM is NTCP, a ROI is one or plural of
normal tissues near the tumour. Radiation dose information of a ROI typically is either of the dose-volume
histogram (DVH)DVH, or one or more dose-volume indices specific to the CBEM model. Examples of such
values include average doses, maximum doses, or indices calculated from the DVH.
Before being input in the CBEM calculations, it is necessary to consider conversion of radiation dose
information (dose conversion) under appropriate assumptions. Examples of such considerations include
but are not limited to dose conversions in relation to the differences in radiation beam types and
treatment schedules (number of fractions and prescription doses per fraction) between the targe
...

FINAL
TECHNICAL ISO/DTR
DRAFT
REPORT 24290
ISO/TC 215
Health informatics — Datasets
Secretariat: ANSI
and data structure for clinical and
Voting begins on:
2023-02-21 biological evaluation metrics in
radiotherapy
Voting terminates on:
2023-04-18
Informatique de santé — Jeux de données et structure de
données pour les métriques d'évaluation clinique et biologique en
radiothérapie
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTR 24290:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

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ISO/DTR 24290:2023(E)
FINAL
TECHNICAL ISO/DTR
DRAFT
REPORT 24290
ISO/TC 215
Health informatics — Datasets
Secretariat: ANSI
and data structure for clinical and
Voting begins on:
biological evaluation metrics in
radiotherapy
Voting terminates on:
Informatique de santé — Jeux de données et structure de
données pour les métriques d'évaluation clinique et biologique en
radiothérapie
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/DTR 24290:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/DTR 24290:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 3
5 CBEMs in EBRT .4
5.1 General . 4
5.2 CBEMs . 4
5.3 Use case of CBEMs . 5
5.3.1 Selection of the EBRT modality . 5
5.3.2 Clinical trials . 5
5.4 Existing data format for CBEMs . 6
6 Datasets and data structure for a CBEM . 6
6.1 General . 6
6.2 Datasets and data structure . 6
6.2.1 Structure of the CBEM report . 6
6.2.2 Structure of the body part . 6
6.2.3 Patient condition information . 6
6.2.4 Treatment plan information. 7
6.2.5 CBEM information . 7
6.2.6 Comments on CBEM report . 9
Annex A (informative) Example of a CBEM model and related data elements .10
Bibliography .12
iii
© ISO 2023 – All rights reserved

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ISO/DTR 24290:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non­governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
  © ISO 2023 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/DTR 24290:2023(E)
Introduction
Radiotherapy or radiation therapy is a treatment method used mostly in cancer care. Due to rapid
technical advances of the radiotherapy treatment modalities, it is becoming increasingly important to
select an appropriate radiotherapy treatment modality for individual patients by considering patient
conditions and the resources that are required.
In the case of external-beam radiation therapy (EBRT), where the therapeutic radiation beams are
emitted from a machine outside the body of the patient, treatment planning is performed prior to
treatment. When selecting a treatment modality from among possible candidates, treatment plans are
made for the candidates, if necessary, and then the dosimetric indices and/or radiobiological metrics
corresponding to the treatment plans are compared.
Tumour control probability (TCP) and normal tissue complication probability (NTCP) are among
the metrics used in the comparisons. They are simple phenomenological models based on clinical
[12]
observations which are described in ICRU 83 as clinical and biological evaluation metrics (CBEMs),
along with other metrics such as equivalent uniform dose, conformity and homogeneity indices.
Recently, more sophisticated models incorporating non-dosimetric patient factors, spatial dose metrics
and ­omics elements (e.g. radiomics and proteomics) have also received attention and some of them are
starting to be referred to in clinical trials in some countries.
For wider and safer use of CBEMs in clinical practice and clinical trials, it is important to provide
an effective framework for ensuring the traceability of calculated metrics. Standardization of data
formats for reporting calculated CBEMs is one possible way. However, no attention has been paid to
such standardization to date, while there is active research on new metrics or new models as well as
increasing attention to transparent reporting of developed models.
This document describes datasets and data structure for the reporting of CBEMs, especially of simple
model types of TCP and NTCP. Scientific aspects of reliability of CBEMs are not in the scope of this
document. Because of the variety of CBEM models, when an evaluated CBEM is to be reported and/
or referred to, it is important to report and/or refer to the value of the calculated CBEM along with
information about the CBEM model itself as well as with dose information and non­dosimetric factors
of the patient that are used in the calculation. It is also important to include descriptions about
uncertainties, underlying assumptions, limitations and situations for application of the CBEM model.
In general, the dose information of the treatment plan used in the calculations (dose­volume histogram
(DVH) in most cases) is converted to match the model definition; for instance, adjusting the differences
in fraction size between the plan of the patient and the reference fraction size of the CBEM model. This
means that the apparent values of the doses (e.g. maximum dose and mean dose) used in the calculation
are CBEM-model-specific. To ensure traceability, inclusion of the description about the process of
such dose conversions along with the value of the representative dose values would be a great help.
This document provides datasets and data structure for CBEM reporting by considering the above
mentioned aspects.
While this document is not intended to cover the reporting of CBEMs by contemporary sophisticated
models, the data structures described in this document can apply to the reporting of them as well.
v
© ISO 2023 – All rights reserved

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TECHNICAL REPORT ISO/DTR 24290:2023(E)
Health informatics — Datasets and data structure for
clinical and biological evaluation metrics in radiotherapy
1 Scope
This document reports on the datasets and a data structure for reporting clinical and biological
evaluation metrics (CBEMs). The reporting of radiation dose estimates is outside the scope of this
document.
This document is applicable to CBEMs for external-beam radiation therapy (EBRT) modalities, but not
CBEMs for brachytherapy or molecular radiotherapy.
Various types of radiotherapy treatment modalities are available for cancer care. Consequently, there
is a growing awareness of the need for objective schemes that will contribute to enable the selection of
an appropriate radiotherapy treatment modality for individual patients. The use of CBEMs, the metrics
associated with a certain radiotherapy treatment plan for a patient, is attracting attention for clinical
purposes in the field of EBRT. In anticipation of the clinical use of CBEMs, the importance of research on
clinical and scientific aspects of CBEMs is increasing, in concert with the importance of establishing a
standardized data format for reporting of specifics of a CBEM.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
data element
unit of data that is considered in context to be indivisible
Note 1 to entry: The definition states that a data element is “indivisible” in some context. This means it is possible
that a data element considered indivisible in one context (e.g. telephone number) can be divisible in another
context (e.g. country code, area code, local number).
[SOURCE: ISO/IEC 11179-1:2023, 3.3.4, modified — Example deleted.]
3.2
Digital Imaging and Communications in Medicine
DICOM
standard for the communication and management of medical imaging information and related data
Note 1 to entry: The DICOM Standard facilitates interoperability of medical imaging equipment.
Note 2 to entry: DICOM is defined in ISO 12052.
[SOURCE: ISO/IEC 39794­16:2021, 3.16]
1
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ISO/DTR 24290:2023(E)
3.3
dose fractionation
method of administration of radiation in which the absorbed dose is divided into two or more fractions
separated in time
[SOURCE: IEV ref 881­11­18]
3.4
dose-volume histogram
DVH
dose as a distribution-function or frequency-function over a specified volume
[SOURCE: ICRU 50, modified — Abbreviated term “DVH” added.]
3.5
endpoint
principal indicator(s) used for providing the evidence for clinical performance, effectiveness
or safety in a clinical investigation
[SOURCE: ISO 14155:2020, 3.22]
3.6
intensity-modulated radiation therapy
IMRT
treatment procedure requiring, in general, the coordinated control of photon or electron fluence, beam
orientation relative to the patient, and beam size of the external beam, either in a continuous or a
discrete manner, and as pre-determined by a treatment plan (3.12)
Note 1 to entry: The primary purpose of IMRT is to improve the conformity of the dose distribution to the planned
target volume, while minimizing dose to surrounding healthy tissue.
[SOURCE: IEC 60976:2016, 3.2.7]
3.7
numerical value equation
numerical quantity value equation
mathematical relation between numerical quantity values, based on a given quantity equation and
specified measurement units
[SOURCE: ISO/IEC Guide 99:2007, 1.25, modified — Examples deleted.]
3.8
radiotherapy
radiation therapy
therapy that uses ionizing radiation to kill cells and shrink pathological tissues
Note 1 to entry: Radiation may be delivered by a machine outside the body (external-beam radiation therapy),
or it may come from radioactive material placed in the body near cancer cells (brachytherapy) or from
radiopharmaceutical administered to the patient (molecular radiotherapy).
[SOURCE: ISO 12749­6:2020, 3.3.2]
3.9
radiotherapy treatment planning system
RTPS
device, usually a programmable electrical medical system including its associated peripherals, that is
used to simulate the application of radiation to a patient for a proposed radiotherapy treatment
Note 1 to entry: It usually, but not necessarily, provides estimations of absorbed dose distribution in human
tissue using a particular algorithm or algorithms. These algorithms provide simulations of radiation that is
typically from, but not necessarily limited to, medical electron accelerators, gamma beam therapy equipment, or
in brachytherapy from radioactive sources.
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ISO/DTR 24290:2023(E)
[SOURCE: IEC 62083:2009, 3.1.6]
3.10
region of interest
ROI
sub-dataset picked out from the entire dataset for a specific purpose
[SOURCE: ISO 20263:2017, 3.1.24]
3.11
relative biological effectiveness
RBE
ratio of the absorbed dose of a reference radiation to the absorbed dose of the radiation
of interest, generally X-ray or gamma ray, that produces the same level of biological effect
Note 1 to entry: The term should only be used in radiobiology.
[SOURCE: IEV ref 881­17­03]
3.12
treatment plan
all patient and dosimetric information that is intended for use by appropriately qualified persons
for the purpose of prescribing or administering radiotherapy (3.8), including any information to be
transmitted to other equipment
Note 1 to entry: A printed or plotted treatment plan is referred to as a treatment plan report.
[SOURCE: IEC 62083:2009, 3.1.8]
3.13
treatment planning
process of establishing the treatment plan (3.12)
[SOURCE: IEC 62083:2009, 3.1.9]
4 Abbreviated terms
CBEM clinical and biological evaluation metric
CI confidence interval
DICOM Digital Imaging and Communications in Medicine
DVH dose­volume histogram
EBRT external-beam radiation therapy
IMRT intensity-modulated radiation therapy
LOINC Logical Observation Identifiers Names and Codes (Regenstrief Institute, Inc.)
NTCP normal tissue complication probability
RBE relative biological effectiveness
ROI region of interest
RTPS radiotherapy treatment planning system
TCP tumour control probability
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ISO/DTR 24290:2023(E)
5 CBEMs in EBRT
5.1 General
EBRT is a form of radiotherapy for delivering a beam or beams of ionizing radiation from outside the
body of patients. There are several different types of modalities of EBRT (EBRT modality) regarding
beam types and ways of forming dose distributions in the patient body, each provided by a specific
device or system. For specific patients, a suitable EBRT modality is selected among those available by
considering the patient condition and the resources required. Recently, the use of CBEMs for treatment
plans of EBRT has been gaining attention in clinical practice and for research purposes.
5.2 CBEMs
[12]
In ICRU 83 , the concept of CBEM is described in the section of “Level 3 Reporting” for intensity-
modulated radiation therapy (IMRT). IMRT is one EBRT modality, however, the described concept of
[12]
the CBEM can also be applicable to other EBRT modalities. In ICRU 83 , TCP, NTCP and combination
metrics of TCP and NTCP are described. This document examines TCP and NTCP as CBEMs but does not
examine combination metrics of these two.
The CBEM is a metric which is associated with a treatment plan. Multiple CBEMs can be associated with
one treatment plan, e.g. on metrics for different endpoints and/or by different CBEM models.
A schematic figure of the calculation process of a CBEM is shown in Figure 1. A CBEM is calculated
using a CBEM model which is expressed as one or multiple numerical value equations. The input to the
equations is the radiation dose information of a region of interest (ROI) for a treatment plan, which
corresponds to the definition of t
...