Stereotactic Magnetic Resonance Guided Radiation Therapy

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04115254
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dana-Farber Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jonathan Leeman, MD
Principal Investigator Affiliation	Brigham and Women's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases, Oligoprogressive Nodal Metastases, Metachronous Nodal Metastases, Synchronous Nodal Metastases, Mesothelioma, Spine Metastases, Brain Metastases, Borderline Resectable Pancreatic Carcinoma

Additional Details

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 to treat cancer. The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer. In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Arms & Interventions