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NCT03824366 Clinical Trial

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

Metastasis Clinical Trial

— MAP-RT  

Official title:
Pilot Study of Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03824366
Other study ID # 201901172
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 23, 2019
Est. completion date January 14, 2022

Study information
Verified date January 2023
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 14, 2022
Est. primary completion date January 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Volumetric MR imaging
This will most frequently be supine with arms positioned so not in the way of treatment beams.
Radiation:
• Radiation therapy
-Standard of care

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
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