Jump: MR Simulation For Radiation Therapy Master Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI Simulator, Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments
Overview
This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.
Detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the feasibility and safety of an investigational intervention. "Investigational" means that the process targeting high doses of radiation to the tumor based on MRI is still being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided dose planning. The U.S. Food and Drug Administration (FDA) has cleared MRI planning for use.
* In Phase I of this study, will prospectively determine the feasibility of using an MRI simulator to plan radiation therapy. * In Phase II, the efficacy of adjusting RT based on MRI simulation will be explored, either by utilizing an MRI-simulation and synthetic CT to plan treatment or by dose-painting based on functional MRI data
Interventions
- Device MRI Simulator
Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data. - Radiation Radiation Therapy
In Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols.
Primary outcome measures
- Feasibility of acquiring MRI simulation prior to radiation therapy planning [Time frame: 1 Year]
- Proportion of patients with QOL decline exceeding 2 x MID [Time frame: baseline up to 24 months]
Secondary outcome measures (8)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Time frame: 24 Months]
- MRI evidence of disease at 2 years from treatment initiation. [Time frame: 24 Months]
- PSA progression (nadir + 2) at 2 years from treatment initiation [Time frame: 24 months]
- Progression free survival [Time frame: 24 months]
- Change in target volumes between CT simulation and MRI simulation [Time frame: 24 Months]
- Change in coverage of target volumes between CT simulation and MRI simulation [Time frame: 24 Months]
- Change in dose to organs at risk (OARs) between CT simulation and MRI simulation [Time frame: 24 Months]
- Performance of the synthetic CT in RT planning [Time frame: 24 Months]
Eligibility criteria
Inclusion criteria
- Participants must have a confirmed malignancy requiring radiation therapy.
- Age: 18 years or older
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
- Disease-specific eligibility criteria will be specified in the appropriate subprotocol.
Exclusion criteria
- For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast. Note: If patient will not receive contrast, this is not applicable
- Participants who cannot undergo an MRI
- Disease-specific exclusion criteria will be specified in the appropriate subprotocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Brigham and Women Hospital — Boston
- Dana Farber Cancer Institute — Boston
Identifiers
NCT: NCT04545957 · 19-759