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Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction | Clinical Trials | Clareo Health

COMPLETEDNA

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)

NCT04939246•Baptist Health South Florida

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject must be ≥18 years of age at the time of study enrollment
•2. 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
•3. Any lesion that would receive SABR under this study protocol is no larger than 5 cm in greatest dimension
•4. 1-10 total lesions that would receive SABR
•5. If multiple lesions are treated, they must be at least 3 cm apart
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•7. Life expectancy at least 6 months
•8. 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.
•9. Patients receiving hormonal therapy or immunotherapy such as immune checkpoint inhibitor that had begun at least 4 weeks prior to SABR will be allowed.

Exclusion Criteria

•1. Subject has contraindication to having an MRI scan
•2. 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
•3. Subject has received cytotoxic chemotherapy or investigational agent within 2 weeks of SBRT
•4. Subject has uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
•5. Subject has any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 \> grade 2) from previous anti-cancer therapy
•6. 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
•7. Subject has received prior radiation therapy that directly overlaps any radiation therapy given in this study
•8. 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
•9. Female subject who are pregnant or breastfeeding
•10. 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.

Locations (2)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Key Dates

Start Date

June 18, 2021

Primary Completion Date

July 17, 2024

Completion Date

July 17, 2024

Last Updated

July 17, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Carcinoma

Interventions

Stereotactic ablative body radiation therapy

RADIATION

BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers

NCT04021043

Advanced Malignant Solid NeoplasmMetastatic Carcinoma in the Liver+3 more

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TERMINATEDNA

Immune Checkpoint Inhibitor and MR-guided SBRT for Limited Progressive Metastatic Carcinoma.

NCT04376502

Metastatic Carcinoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers

Immune Checkpoint Inhibitor and MR-guided SBRT for Limited Progressive Metastatic Carcinoma.

Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery

Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA)

α-TEA in Advanced Cancer