ISO/TS 24560-1:2022
(Main)Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
This document provides a principle to determine the parameter settings and operating methods for the evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping MRI in humans with a typical example of the methods; each are distinct MRI technologies that allow for noninvasive observation of soft tissue characteristics. The methods provided in this document are intended for application in the evaluation of the clinical effects of tissue-engineered cartilage or other cartilage regeneration products used in the knee joint, and are also applicable for the evaluation of regenerative cartilage in other joints, although some modification of parameters is needed. This document describes a longitudinal evaluation of the water content, the glycosaminoglycan (GAG) concentration, and the concentration and orientation of collagen fibres in regenerative cartilage when using dGEMRIC and T2-mapping techniques in 1,5 T or 3,0 T magnetic resonance imaging equipment.
Produits médicaux issus de l'ingénierie tissulaire — Évaluation du cartilage par IRM — Partie 1: Évaluation clinique de la régénération du cartilage articulaire du genou par séquences IRM tardives après injection de gadolinium (dGEMRIC) et cartographie T2
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TECHNICAL ISO/TS
SPECIFICATION 24560-1
First edition
2022-07
Tissue-engineered medical
products — MRI evaluation of
cartilage —
Part 1:
Clinical evaluation of regenerative
knee articular cartilage using delayed
gadolimium-enhanced MRI of
cartilage (dGEMRIC) and T2 mapping
Produits médicaux issus de l'ingénierie tissulaire — Évaluation du
cartilage par IRM —
Partie 1: Évaluation clinique de la régénération du cartilage
articulaire du genou par séquences IRM tardives après injection de
gadolinium (dGEMRIC) et cartographie T2
Reference number
© ISO 2022
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 3
5 T2 mapping evaluation in human knee articular cartilage . 4
5.1 Characterization parameters and methods . 4
5.2 T2 value measurement process . 6
5.2.1 Post-processing of imaging . 6
5.2.2 Measurement method . 6
5.2.3 ROIs of regenerative cartilage . 7
5.2.4 ROIs of normal control cartilage . 8
5.3 T2 value evaluation . 8
5.3.1 Purpose of evaluation . 8
5.3.2 In vivo evaluation of regenerative cartilage with T2 value . 8
6 dGEMRIC evaluation in human knee articular cartilage . 9
6.1 Characterization parameters and methods . 9
6.2 T1 value measurement process . 11
6.2.1 Post-processing of imaging . 11
6.2.2 Measurement method . 11
6.2.3 ROIs of regenerative cartilage .12
6.2.4 ROIs of normal control cartilage .12
6.3 ΔR1 value calculation . 12
6.4 ΔR1 value evaluation .12
6.4.1 Purpose of evaluation .12
6.4.2 In vivo evaluation of regenerative cartilage with ΔR1 values .13
7 Acceptable standard for MR evaluation .14
7.1 Requirements for MR equipment . 14
7.2 Requirements for MR parameters. 14
7.3 Requirements for the MR longitudinally evaluation . 14
7.4 Exclusion criteria . 14
8 Limitation .15
Annex A (informative) Example of measurement results .16
Annex B (informative) Introduction of T1ρ MR Imaging technology .26
Bibliography .28
iii
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
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 7, Tissue-engineered medical products.
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
Introduction
Tissue-engineered cartilage has shown desirable results for the repair of cartilage defects, and histologic
findings indicate that the repaired tissue has a hyaline-like cartilage structure. Kang H.J. et al., Zheng
M.H. et al. and Behrens P. et al. reported that the histologic change after matrix-associated autologous
[1-3]
chondrocyte implantation/transplantation (MACI/MACT) was a hyaline-like cartilage. The knee
articular cartilage can also be repaired or regenerated via other tissue engineering approaches using
other seed cells such as mesenchymal stem cells or even by tissue regeneration free of external seed
[4-6]
cells . MACI and other approaches lead to a maturation of the cartilage matrix over time with the
development of an organized collagen architecture. For long-term follow-up of regenerative cartilage,
clinical scores and morphological evaluations are commonly used. Furthermore, histological evaluation
from arthroscopic biopsies provides a gold standard for morphological and biochemical assessments
of regenerative cartilage tissue. However, this process is invasive and unacceptable for patients after
cartilage repair surgery. Magnetic resonance (MR) is a noninvasive technique that can be used for the
evaluation of a cartilage microstructure. Xu X and other researchers reported that MR-based biochemical
imaging techniques, such as delayed gadolinium-enhanced MRI of the cartilage (dGEMRIC) and T2
[7-12]
mapping, show the capability of evaluating the biochemical character of articular cartilage . The
T2 relaxation time is sensitive to the content of effective hydrogen atoms, and thus to the concentration
[13]
of collagen, the main component of cartilage extracellular matrix . Besides, the orientation changes
in the collagen network of articular cartilage produce the depthwise T2 anisotropy through the magic
[14]
angle effect . The dGEMRIC technique enables an indirect estimation of the fixed charge density (FCD)
[15]
of cartilage, which mainly arises from the aggregated proteoglycan biomacromolecules . Since both
collagen and proteoglycan components are important for determining the functional characteristics
of cartilage, a combination of T2 mapping and dGEMRIC techniques provides a better evaluation of
articular regenerative cartilage. Therefore, standardization of T2 mapping and dGEMRIC techniques is
needed for the evaluation of regenerative articular cartilage.
This document is intended to guide the clinical biochemical evaluation of regenerative articular
cartilage with MR. dGEMRIC and T2 mapping are recommended for the clinical evaluation of
regenerative cartilage. These techniques have been used for patients who received tissue-engineered
cartilage implantation or transplantation (MACI/MACT). The validation data from different hospitals
are provided Annex A.
This document provides general principles for imaging and the measurement method of T2 mapping
and dGEMRIC of knee cartilage using 1,5 T or 3,0 T MRI equipment. These techniques are also applicable
for other articular cartilage, such as the ankle joint, hip joint, and shoulder joint, but the imaging
parameters should be adjusted and modified for better image quality.
v
TECHNICAL SPECIFICATION ISO/TS 24560-1:2022(E)
Tissue-engineered medical products — MRI evaluation of
cartilage —
Part 1:
Clinical evaluation of regenerative knee articular cartilage
using delayed gadolimium-enhanced MRI of cartilage
(dGEMRIC) and T2 mapping
1 Scope
This document provides a principle to determine the parameter settings and operating methods for the
evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping MRI
in humans with a typical example of the methods; each are distinct MRI technologies that allow for
noninvasive observation of soft tissue characteristics.
The methods provided in this document are intended for application in the evaluation of the clinical
effects of tissue-engineered cartilage or other cartilage regeneration products used in the knee joint,
and are also applicable for the evaluation of regenerative cartilage in other joints, although some
modification of parameters is needed.
This document describes a longitudinal evaluation of the water content, the glycosaminoglycan (GAG)
concentration, and the concentration and orientation of collagen fibres in regenerative cartilage when
using dGEMRIC and T2-mapping techniques in 1,5 T or 3,0 T magnetic resonance imaging equipment.
2 Normati
...
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