What this study is
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.
What's being tested
- MRI Simulator
Intervention · DEVICE
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 Therapy
Intervention · RADIATION
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.
Study details
- 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
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Prostate Cancer · Recurrent Adenocarcinoma · Liver Cancer · Head and Neck Cancer
- Enrolling
- 86 people
- Starts
- 2020-10-14
- Est. completion
- 2030-10-22
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openContact for every open site
- Raymond Mak, MD · Contactrmak@partners.org
- Raymond Mak, MD · Principal investigator
Brigham and Women Hospital
Boston, Massachusetts, United States
RecruitingDana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Study team
Sponsor
Brigham and Women's Hospital
Study ID 19-759
Principal investigator
Raymond Mak, MD
Brigham and Women's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.