NCT04939246

Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction

A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Stereotactic ablative body radiation therapy (SABR) is a highly-focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.

Conditions

• Metastatic Carcinoma

Interventions

Type	Name	Description
RADIATION	Stereotactic ablative body radiation therapy	Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.

Timeline

• Start date: 2021-06-18
• Primary completion: 2024-07-17
• Completion: 2024-07-17
• First posted: 2021-06-25
• Last updated: 2025-07-17
• Results posted: 2025-07-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study