Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04368702

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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