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

NCT04939246 | Completed Results DMC FDA Device

• 1 other identifier: 2020-CHU-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With SABR Successfully Delivered in One Fraction

  To be considered successful, SABR treatment must meet the following criteria: 1. Successful completion of treatment to each lesion within 3 days of intended treatment date 2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion for at least 80% of treated lesions 3. Image guidance verification of treatment delivery within 5 mm of the planned delivery

  through study completion, an average of 1 year

• Number of Patients Demonstrating Tolerability

  Number of patients that meet the following criteria: 1. No greater than 4 of 30 patients experience grade 3 or higher acute toxicity is attributable to SABR within 90 days of completing SABR 2. No grade 5 toxicity is attributed to SABR

  through study completion, an average of 1 year

Secondary Outcomes (4)

• One-year Local Control

  12 months

• Percent of Participants With One-year Overall Survival

  12 months

• Number of Participants With Acute and Late Toxicity Results

  12 months

• Change in Participant Reported Quality of Life Questionnaire

  baseline, 3, 6, 9, and 12 months after treatment

Study Arms (1)

Single-fraction SABR

OTHER

Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.

Radiation: Stereotactic ablative body radiation therapy

Interventions

Stereotactic ablative body radiation therapy RADIATION

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.

Single-fraction SABR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be ≥18 years of age at the time of study enrollment
• Subject must have Biopsy-confirmed primary or metastatic carcinoma with involvement of the lung, liver, adrenal gland, pancreas, kidney, and/or abdominal/pelvic lymph node that would receive SABR
• Any lesion that would receive SABR under this study protocol is no larger than 5 cm in greatest dimension
• total lesions that would receive SABR
• If multiple lesions are treated, they must be at least 3 cm apart
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Life expectancy at least 6 months
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it's the patient preferred method. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Patients receiving hormonal therapy or immunotherapy such as immune checkpoint inhibitor that had begun at least 4 weeks prior to SABR will be allowed.

You may not qualify if:

• Subject has contraindication to having an MRI scan
• Subject has central or ultra-central lung tumor that would receive SABR on this study, defined as a lesion located within 2 cm of the trachea and proximal bronchial tree
• Subject has received cytotoxic chemotherapy or investigational agent within 2 weeks of SBRT
• Subject has uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
• Subject has any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 \> grade 2) from previous anti-cancer therapy
• Subject has any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results
• Subject has received prior radiation therapy that directly overlaps any radiation therapy given in this study
• Subject has received radiation therapy that could lead to an unacceptably high risk of clinically significant normal tissue injury due to high cumulative normal tissue dose as determined by the investigator
• Female subject who are pregnant or breastfeeding
• Subject who has received vascular endothelial growth factor (VEGF) inhibitor such as bevacizumab within 4 weeks prior to study therapy or planned to receive it within 4 weeks after study therapy.

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Viewray Inc.: collaborator

Study Sites (2)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53717, United States

Location

Related Publications (1)

• Chuong MD, Mittauer KE, Bassetti MF, Rojas C, Glide-Hurst C, Kalman NS, Tom MC, Rubens M, Crosby J, Burr A, Tolakanahalli R, Gutierrez AN, Bassiri N, Mehta MP, Kotecha R. Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy in One Fraction (SMART ONE): A Multicenter, Single-Arm, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2025 Jul 15;122(4):957-967. doi: 10.1016/j.ijrobp.2025.03.030. Epub 2025 Mar 28.

  PMID: 40158734 RESULT

Related Links

• MCI - Website

MeSH Terms

Conditions

Carcinoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Director, Concept Development & Data Management
• Organization: Miami Cancer Institute at Baptist Health, Inc.

mciresearchconceptandprotocoldev@baptisthealth.net

(786) 527-9546

Study Officials

• Michael Chuong, MD

  Miami Cancer Institute (MCI) at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 25, 2021
• Study Start: June 18, 2021
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)