NCT04115254 Stereotactic Magnetic Resonance Guided Radiation Therapy
| NCT ID | NCT04115254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 397 participants |
| Start Date | 2019-10-22 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 397 participants in total. It began in 2019-10-22 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer. * The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. * Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures
Eligibility 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
Contact & Investigator
Jonathan Leeman, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT04115254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04115254 currently recruiting?
Yes, NCT04115254 is actively recruiting participants. Contact the research team at JONATHANE_LEEMAN@DFCI.HARVARD.EDU for enrollment information.
Where is the NCT04115254 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT04115254 clinical trial?
NCT04115254 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Jonathan Leeman, MD at Brigham and Women's Hospital. The trial plans to enroll 397 participants.
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