Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy

Not Applicable

Completed

• Conditions: Malignancy; Gastrointestinal Bleeding; Mediastinal Disease; Metastasis; Hemoptysis; Pelvic Bleeding; Superior Vena Cava Syndrome
• Interventions: Device: Volumetric MR imaging; Radiation: Radiation therapy

• Registration Number: NCT03824366
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Study Start: 2019-04-23
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Results First Submitted: 2022-11-21
• Results First Submitted QC: 2023-01-04
• Results First Posted: 2023-01-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative RT)
• Requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease.
• At least 18 years of age.
• Able to understand and willing to sign an IRB-approved written informed consent document.

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Exclusion Criteria

• Pregnant. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
• Medical contraindication to undergoing MR imaging.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volumetric MR imaging planning	Volumetric MR imaging	* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Volumetric MR imaging planning	Radiation therapy	* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy

Primary Outcome Measures

Name	Time	Method
Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.	Completion of enrollment (approximately 29 months)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States