Back to resultsSame-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)
Primary Purpose
Malignancy, Metastasis, Hemoptysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volumetric MR imaging
Radiation therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Malignancy
Eligibility Criteria
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Volumetric MR imaging planning
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03824366
First Posted
January 29, 2019
Last Updated
January 4, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03824366
Brief Title
Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy
Acronym
MAP-RT
Official Title
Pilot Study of Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
January 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignancy, Metastasis, Hemoptysis, Gastrointestinal Bleeding, Pelvic Bleeding, Superior Vena Cava Syndrome, Mediastinal Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volumetric MR imaging planning
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Volumetric MR imaging
Intervention Description
This will most frequently be supine with arms positioned so not in the way of treatment beams.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
-Standard of care
Primary Outcome Measure Information:
Title
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.
Time Frame
Completion of enrollment (approximately 29 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Kim, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices). Participants who opted out of data sharing in the informed consent will not be included.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Researches must provide a methodologically sound proposal. Proposals should be directed to kim.hyun@wustl.edu. To gain access, data requestors will need to sign a data access agreement and provide proof of appropriate regulatory approvals as necessary.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy
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