CONFIRM: Magnetic Resonance Guided Radiation Therapy

Mass General Brigham

Status: Enrolling

Conditions: in Situ Breast Cancer; Bladder Cancer; Gastric Cancer; Mantle Cell Lymphoma; Larynx Cancer; Invasive Breast Cancer

Treatments: Radiation: Viewray MRIdian® Linac

Study type: Interventional

Funder types: Other

Identifiers

NCT04368702

19-665

Details and patient eligibility

About

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

Full description

This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.

In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.

The research study procedures include:

• Screening for eligibility
• Study treatment including evaluations
• Follow up visits
• Questionnaires

This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is 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 radiation. Investigators at other hospitals and academic centers are already using this type of radiation.

The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participants must have histologically or cytologically confirmed malignancy requiring radiation
• Age 18 years of older
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
• Ability to understand and the willingness to sign a written informed consent document.
• Any further criteria listed in the specific disease site cohort

Exclusion Criteria

• History of allergic reactions attributed to gadolinium-based IV contrast

  -- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility

• Severe claustrophobia or anxiety

• Participants who cannot undergo an MRI

• Any other exclusion criteria listed in the specific disease site cohort

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 5 patient groups

Phase I - Gastric Cancer

Experimental group

Description:

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Treatment:

Radiation: Viewray MRIdian® Linac

Phase I - Breast Cancer

Experimental group

Description:

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Treatment:

Radiation: Viewray MRIdian® Linac

Phase I - Mantle Cell Lymphoma

Experimental group

Description:

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Treatment:

Radiation: Viewray MRIdian® Linac

Phase I - Larynx

Experimental group

Description:

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Treatment:

Radiation: Viewray MRIdian® Linac

Phase I - Bladder

Experimental group

Description:

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Treatment:

Radiation: Viewray MRIdian® Linac