NCT04115254 · Dana-Farber Cancer Institute
Stereotactic Magnetic Resonance Guided Radiation Therapy
What this study is about
This is a master forward-looking Phase I-II trial evaluating feasibility and effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2025 · Source of record for eligibility and locations