NCT04115254

Stereotactic Magnetic Resonance Guided Radiation Therapy

A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 397 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
RADIATION	MR-guided Linac	Radiation will be delivered on an MR-guided Linear Accelerator

Timeline

• Start date: 2019-10-22
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2019-10-03
• Last updated: 2025-11-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study