Using MRI-guided radiation therapy for treating certain cancers
Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
This study is testing if using MRI to guide radiation therapy along with chemotherapy can safely and effectively treat patients with gastric and breast cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04368702 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of using magnetic resonance imaging (MRI) to guide radiation therapy combined with chemotherapy for patients with gastric and breast cancers. The study utilizes the MRIdian Linear Accelerator to adapt radiation delivery in real-time, targeting the precise location of tumors. Participants will undergo screening, treatment evaluations, and follow-up visits, while their experiences will be documented through questionnaires. This is a Phase I/II feasibility study, marking the first examination of this MR-guided radiation approach at the institution, although it has been used at other centers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed gastric or breast cancer requiring radiation therapy.
Not a fit: Patients with severe claustrophobia, anxiety, or those unable to undergo an MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise and effective radiation treatments for patients with gastric and breast cancers.
How similar studies have performed: Other institutions have successfully utilized MRI-guided radiation therapy, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Raymond Mak, MD — Dana-Farber Cancer Institute
- Study coordinator: Raymond Mak, MD
- Email: rmak@partners.org
- Phone: 6177328651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.