Breast Cancer Clinical Trial

CONFIRM: Magnetic Resonance Guided Radiation Therapy

Summary

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.

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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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

70

Study ID:

NCT04368702

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Brigham & Women's Hospital
Boston Massachusetts, 02115, United States More Info
Raymond Mak, MD
Contact
Raymond Mak, MD
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Raymond Mak, MD
Contact
Raymond Mak, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

70

Study ID:

NCT04368702

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

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