Actively Recruiting
Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
Led by Brigham and Women's Hospital · Updated on 2026-02-09
70
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using magnetic resonance imaging (MRI) guided radiation therapy combined with chemotherapy to treat patients with gastric and breast cancer. This study is a Phase I/II clinical trial focusing on a special radiation machine called the MRIdian Linear Accelerator. The trial aims to determine if MRI during radiation can help doctors target cancer more precisely, improving treatment delivery. Participants will receive MR-image guided radiation therapy tailored to the specific cancer site following standard treatment guidelines. The study includes screening for eligibility, the treatment itself with ongoing evaluations, follow-up visits, and completion of questionnaires. The trial also considers different cancer types such as gastric cancer, breast cancer, mantle cell lymphoma, larynx cancer, and bladder cancer. Throughout the study, participants will undergo various assessments including tumor evaluation using MRI during treatment, patient-reported outcomes, and monitoring for treatment-related side effects. The primary outcomes involve tumor control over one year and measuring complete pathological response in gastric cancer. Safety and treatment duration will be closely tracked, along with long-term survival and tumor changes observed through MRI. Participation may last up to one year with scheduled follow-up and questionnaires.
CONDITIONS
Brief Title
CONFIRM: Magnetic Resonance Guided Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed malignancy requiring radiation
- Age 18 years or older
- ECOG performance status of 2 or better (Karnofsky score 60% or higher)
- Ability to understand and willingness to sign informed consent
- Meet any additional criteria listed for the specific disease site cohort
You will not qualify if you...
- History of allergic reactions to gadolinium-based intravenous contrast (unless contrast is not used)
- Severe claustrophobia or anxiety
- Inability to undergo MRI
- Any other exclusion criteria listed in the specific disease site cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 weeks
Participants receive MR-image guided radiation therapy administered according to disease site standards. Evaluations are performed during treatment to adapt the radiation precisely to the cancer location.
Multiple visits for radiation treatment over 5 weeks
Duration - Up to 1 year
Participants attend follow-up visits and complete questionnaires to monitor tumor control, treatment-related adverse events, and patient-reported outcomes for up to 1 year after treatment.
Periodic visits and questionnaires up to 1 year
Trial Site Locations
Total: 2 locations
1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
R
Raymond Mak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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