The MOMENTUM study: an international registry for the evidence-based introduction of mr-guided adaptive therapy
Authorsde Mol van Otterloo, S. R.
Christodouleas, J. P.
Blezer, E. L. A.
Erickson, B. A.
Fuller, C. D.
Harrington, K. J.
van der Heide, U. A.
Huddart, R. A.
Intven, M. P. W.
Kirby, A. M.
Minsky, B. D.
Nowee, M. E.
Sarmiento, J. G.
Schultz, C. J.
Tijssen, R. H. N.
Tree, A. C.
van Triest, B.
Hall, W. A.
Verkooijen, H. M.
AffiliationDepartment of Radiation Oncology, University Medical Center Utrecht, Utrecht, Netherlands.
MetadataShow full item record
AbstractPurpose: MR-guided Radiation Therapy (MRgRT) allows for high-precision radiotherapy under real-time MR visualization. This enables margin reduction and subsequent dose escalation which may lead to higher tumor control and less toxicity. The Unity MR-linac (Elekta AB, Stockholm, Sweden) integrates a linear accelerator with a 1.5T diagnostic quality MRI and an online adaptive workflow. A prospective international registry was established to facilitate the evidence-based implementation of the Unity MR-linac into clinical practice, to systemically evaluate long-term outcomes, and to aid further technical development of MR-linac-based MRgRT. Methods and Results: In February 2019, the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-linac study (MOMENTUM) started within the MR-linac Consortium. The MOMENTUM study is an international academic-industrial partnership between several hospitals and industry partner Elekta. All patients treated on the MR-linac are eligible for inclusion in MOMENTUM. For participants, we collect clinical patient data (e.g., patient, tumor, and treatment characteristics) and technical patient data which is defined as information generated on the MR-linac during treatment. The data are captured, pseudonymized, and stored in an international registry at set time intervals up to two years after treatment. Patients can choose to provide patient-reported outcomes and consent to additional MRI scans acquired on the MR-linac. This registry will serve as a data platform that supports multicenter research investigating the MR-linac. Rules and regulations on data sharing, data access, and intellectual property rights are summarized in an academic-industrial collaboration agreement. Data access rules ensure secure data handling and research integrity for investigators and institutions. Separate data access rules exist for academic and industry partners. This study is registered at ClinicalTrials.gov with ID: NCT04075305 (https://clinicaltrials.gov/ct2/show/NCT04075305). Conclusion: The multi-institutional MOMENTUM study has been set up to collect clinical and technical patient data to advance technical development, and facilitate evidenced-based implementation of MR-linac technology with the ultimate purpose to improve tumor control, survival, and quality of life of patients with cancer.
Citationde Mol van Otterloo SR, Christodouleas JP, Blezer ELA, Akhiat H, Brown K, Choudhury A, et al. The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy. Front Oncol. 2020;10:1328.
JournalFrontiers in Oncology
- First 500 Fractions Delivered with a Magnetic Resonance-guided Radiotherapy System: Initial Experience.
- Authors: Sahin B, Zoto Mustafayev T, Gungor G, Aydin G, Yapici B, Atalar B, Ozyar E
- Issue date: 2019 Dec 24
- A daily end-to-end quality assurance workflow for MR-guided online adaptive radiation therapy on MR-Linac.
- Authors: Chen X, Ahunbay E, Paulson ES, Chen G, Li XA
- Issue date: 2020 Jan
- 4D-MRI driven MR-guided online adaptive radiotherapy for abdominal stereotactic body radiation therapy on a high field MR-Linac: Implementation and initial clinical experience.
- Authors: Paulson ES, Ahunbay E, Chen X, Mickevicius NJ, Chen GP, Schultz C, Erickson B, Straza M, Hall WA, Li XA
- Issue date: 2020 Jul
- Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance.
- Authors: Gani C, Boeke S, McNair H, Ehlers J, Nachbar M, Mönnich D, Stolte A, Boldt J, Marks C, Winter J, Künzel LA, Gatidis S, Bitzer M, Thorwarth D, Zips D
- Issue date: 2021 Jan
- The MRI-Linear Accelerator Consortium: Evidence-Based Clinical Introduction of an Innovation in Radiation Oncology Connecting Researchers, Methodology, Data Collection, Quality Assurance, and Technical Development.
- Authors: Kerkmeijer LG, Fuller CD, Verkooijen HM, Verheij M, Choudhury A, Harrington KJ, Schultz C, Sahgal A, Frank SJ, Goldwein J, Brown KJ, Minsky BD, van Vulpen M, MR-Linac Consortium Clinical Steering Committee.
- Issue date: 2016