We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03824366
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignancy Metastasis Hemoptysis Gastrointestinal Bleeding Pelvic Bleeding Superior Vena Cava Syndrome Mediastinal Disease Device: Volumetric MR imaging Radiation: Radiation therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 23, 2019
Actual Primary Completion Date : January 14, 2022
Actual Study Completion Date : January 14, 2022

Resource links provided by the National Library of Medicine


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




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 [ Time Frame: Completion of enrollment (approximately 29 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824366


Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Hyun Kim, M.D. Washington University School of Medicine
Additional Information:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03824366    
Other Study ID Numbers: 201901172
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemoptysis
Mediastinal Diseases
Superior Vena Cava Syndrome
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Thoracic Diseases
Vascular Diseases
Cardiovascular Diseases