TY - JOUR
T1 - Clinical trials of MRS methods
AU - Julia-Sape, Margarida
AU - Arias-Mendoza, Fernando
AU - Griffiths, John R.
PY - 2015/1/1
Y1 - 2015/1/1
N2 - © 2015 John Wiley & Sons, Ltd. 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.
AB - © 2015 John Wiley & Sons, Ltd. 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.
KW - artifacts
KW - clinical trial
KW - MRS
KW - multicenter
KW - quality control
UR - http://www.scopus.com/inward/record.url?scp=85021367075&partnerID=8YFLogxK
U2 - 10.1002/9780470034590.emrstm1474
DO - 10.1002/9780470034590.emrstm1474
M3 - Article
SN - 2055-6101
VL - 4
SP - 779
EP - 788
JO - eMagRes
JF - eMagRes
IS - 4
ER -