Using MRI to guide radiation therapy for various cancers
A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
This study is testing if using MRI scans to adjust radiation therapy can help people with different types of cancer, like pancreatic and lung cancer, feel better and control their tumors more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 397 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04115254 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with various cancers, including pancreatic, lung, renal, and prostate cancers. The study is divided into two phases: the first phase assesses the safety and feasibility of the treatment, while the second phase focuses on its effectiveness in controlling tumors and improving patient-reported outcomes. The approach involves adjusting radiation treatments based on daily MRI scans to enhance precision in targeting tumors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed malignancies requiring stereotactic body radiation therapy and tumor sizes of 7cm or less.
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 treatment could provide a more effective and personalized radiation therapy option for patients with specific types of cancer.
How similar studies have performed: While this approach is novel in its specific application, other studies have shown promise with MR-guided radiation therapy in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details. * Tumor size ≤ 7cm * 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. * Specific eligibility requirements for each disease site with be covered in each specific cohort. Exclusion Criteria: * Specific exclusion requirements for each disease site with be covered in each specific cohort * History of allergic reactions attributed to gadolinium-based IV contrast. \-- Note: If a patient will not receive contrast, this is not applicable * Pregnant women are excluded from this study. * Severe claustrophobia or anxiety * Participants who cannot undergo an MRI
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: Jonathan Leeman, MD — Brigham and Women's Hospital
- Study coordinator: Jonathan Leeman, MD
- Email: JONATHANE_LEEMAN@DFCI.HARVARD.EDU
- Phone: 617-732-6452
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.