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Clinical Trials of MRS Methods

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https://www.repository.cam.ac.uk/handle/1810/253753

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Julià-Sapé et al 2015 eMagRes.pdf (1.05 MB)

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Article

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Abstract

In order to determine the applicability of noninvasive magnetic resonance spectroscopy (MRS) to the study of a diseased tissue or organ in the human body, it is necessary to determine if MRS is safe and effective. This is usually the primary purpose of a clinical trial of a novel method. A clinical trial for MRS may also reveal which technical approach works best for the specific application and characteristics of the population being studied. In this article, we discuss the legal, ethical, and scientific requirements to be considered before the start of a clinical trial of an MRS protocol, as well as constraints that may arise during its execution. MRS‐specific issues arising from a couple of successful clinical MRS trials for classifying brain tumors with 1H MRS (INTERPRET and eTUMOUR) and body tumors with 31P MRS (the Cooperative Group on MRS Application in Cancer, CoGMAC) serve as illustrative examples.

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Keywords

32 Biomedical and Clinical Sciences, 3211 Oncology and Carcinogenesis, Rare Diseases, Cancer, Clinical Trials and Supportive Activities, Brain Cancer, Biomedical Imaging, Brain Disorders, Clinical Research, 4.1 Discovery and preclinical testing of markers and technologies

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Emagres

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Journal ISSN

2055-6101

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Publisher

Wiley

Publisher DOI

https://doi.org/10.1002/9780470034590.emrstm1474

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Sponsorship
JRG thanks The University of Cambridge, CRUK [grant number C14303/A17197] and Hutchison Whampoa Limited. FAM thanks the National Cancer Institute (NIH) from the United States for their support through grants R01-CA118559 and R21-CA152858. FAM wish to thank Dr. Radka Stoyanova from the University of Miami for helpful contributions to the principal component analysis discussion. MJ is funded by SAF2014-52332-R from MINECO (ES) and CIBER-BBN (Centro de Investigación Biomédica en Red – Bioingeniería, Biomateriales y Nanomedicina [http://www.ciber-bbn.es/en]), an initiative of the Instituto de Salud Carlos III (Spain) co-funded by EU FEDER funds.

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Scholarly Works - Cancer Research UK Cambridge Institute
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