TY - JOUR
T1 - Integration of quantitative imaging biomarkers in clinical trials for MR-guided radiotherapy
T2 - Conceptual guidance for multicentre studies from the MR-Linac Consortium Imaging Biomarker Working Group
AU - van Houdt, Petra J.
AU - Saeed, Hina
AU - Thorwarth, Daniela
AU - Fuller, Clifton D.
AU - Hall, William A.
AU - McDonald, Brigid A.
AU - Shukla-Dave, Amita
AU - Kooreman, Ernst S.
AU - Philippens, Marielle E.P.
AU - van Lier, Astrid L.H.M.W.
AU - Keesman, Rick
AU - Mahmood, Faisal
AU - Coolens, Catherine
AU - Stanescu, Teodor
AU - Wang, Jihong
AU - Tyagi, Neelam
AU - Wetscherek, Andreas
AU - van der Heide, Uulke A.
N1 - Funding Information:
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. van der Heide receives industry grant support from Philips Healthcare and Elekta AB and ITEA project (‘Starlit’). Dr. Fuller received/receives funding and salary support related to this project from: the National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Research Education Programs for Residents and Clinical Fellows Grant ( R25EB025787-01 ); the National Institute for Dental and Craniofacial Research Establishing Outcome Measures Award ( 1R01DE025248 / R56DE025248 ) and Academic Industrial Partnership Grant ( R01DE028290 ); National Cancer Institute (NCI) Early Phase Clinical Trials in Imaging and Image-Guided Interventions Program ( 1R01CA218148 ); an NIH / NCI Cancer Center Support Grant (CCSG) Pilot Research Program Award from the UT MD Anderson CCSG Radiation Oncology and Cancer Imaging Program ( P30CA016672 ); and an NCI-NSF Smart Connected Health Program ( R01 CA257814 ). Direct infrastructure support is provided to Dr. Fuller by the multidisciplinary Stiefel Oropharyngeal Research Fund of the University of Texas MD Anderson Cancer Center Charles and Daneen Stiefel Center for Head and Neck Cancer and the Cancer Center Support Grant ( P30CA016672 ) and the MD Anderson Program in Image-guided Cancer Therapy. Dr. Fuller has received direct industry grant support, in-kind support, honoraria, and travel funding from Elekta AB related to this project. Ms. McDonald receives salary and funding support from the NIH NIDCR Ruth L. Kirschstein National Research Service Award ( NRSA ) Individual Predoctoral Fellowship ( F31DE029093 ) and a Dr. John J. Kopchick Fellowship through the UT MD Anderson UTHealth Graduate School of Biomedical Sciences. All remaining authors have declared no conflicts of interest.
Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2021/8
Y1 - 2021/8
N2 - Quantitative imaging biomarkers (QIBs) derived from MRI techniques have the potential to be used for the personalised treatment of cancer patients. However, large-scale data are missing to validate their added value in clinical practice. Integrated MRI-guided radiotherapy (MRIgRT) systems, such as hybrid MRI-linear accelerators, have the unique advantage that MR images can be acquired during every treatment session. This means that high-frequency imaging of QIBs becomes feasible with reduced patient burden, logistical challenges, and costs compared to extra scan sessions. A wealth of valuable data will be collected before and during treatment, creating new opportunities to advance QIB research at large. The aim of this paper is to present a roadmap towards the clinical use of QIBs on MRIgRT systems. The most important need is to gather and understand how the QIBs collected during MRIgRT correlate with clinical outcomes. As the integrated MRI scanner differs from traditional MRI scanners, technical validation is an important aspect of this roadmap. We propose to integrate technical validation with clinical trials by the addition of a quality assurance procedure at the start of a trial, the acquisition of in vivo test-retest data to assess the repeatability, as well as a comparison between QIBs from MRIgRT systems and diagnostic MRI systems to assess the reproducibility. These data can be collected with limited extra time for the patient. With integration of technical validation in clinical trials, the results of these trials derived on MRIgRT systems will also be applicable for measurements on other MRI systems.
AB - Quantitative imaging biomarkers (QIBs) derived from MRI techniques have the potential to be used for the personalised treatment of cancer patients. However, large-scale data are missing to validate their added value in clinical practice. Integrated MRI-guided radiotherapy (MRIgRT) systems, such as hybrid MRI-linear accelerators, have the unique advantage that MR images can be acquired during every treatment session. This means that high-frequency imaging of QIBs becomes feasible with reduced patient burden, logistical challenges, and costs compared to extra scan sessions. A wealth of valuable data will be collected before and during treatment, creating new opportunities to advance QIB research at large. The aim of this paper is to present a roadmap towards the clinical use of QIBs on MRIgRT systems. The most important need is to gather and understand how the QIBs collected during MRIgRT correlate with clinical outcomes. As the integrated MRI scanner differs from traditional MRI scanners, technical validation is an important aspect of this roadmap. We propose to integrate technical validation with clinical trials by the addition of a quality assurance procedure at the start of a trial, the acquisition of in vivo test-retest data to assess the repeatability, as well as a comparison between QIBs from MRIgRT systems and diagnostic MRI systems to assess the reproducibility. These data can be collected with limited extra time for the patient. With integration of technical validation in clinical trials, the results of these trials derived on MRIgRT systems will also be applicable for measurements on other MRI systems.
KW - Biomarkers
KW - Image-guided
KW - Magnetic resonance imaging
KW - Multicentre study
KW - Radiotherapy
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U2 - 10.1016/j.ejca.2021.04.041
DO - 10.1016/j.ejca.2021.04.041
M3 - Article
C2 - 34144436
AN - SCOPUS:85107945729
SN - 0959-8049
VL - 153
SP - 64
EP - 71
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -