Clincosm LogoSign in Get a demo

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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03824366
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
32.8
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Volumetric MR imaging
  • Radiation: Radiation therapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Pilot Study of Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)
Actual Study Start Date :
Apr 23, 2019
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Volumetric MR imaging planning

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

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

Outcome Measures

Primary Outcome Measures

  1. Feasibility of same-session MRI-only simulation as measured by the number of participants who receive at least 70% of their scheduled treatment fractions on the first on-table attempt for each respective fraction [Completion of enrollment (approximately 29 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Hyun Kim, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03824366
Other Study ID Numbers:
  • 201901172
First Posted:
Jan 31, 2019
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemoptysis
Mediastinal Diseases
Superior Vena Cava Syndrome
Hemorrhage

Study Results

No Results Posted as of Feb 3, 2022