A Pilot Study of PET/MR for Rectal Cancer Treatment Monitoring and Surveillance
Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of pilot study is to assess the feasibility of FDG-PET/MRI for monitoring rectal cancer disease status in the setting of rectal cancer non-operative management (NOM). Data from this study will be used to guide the design of future clinical trials involving FDG-PET/MRI for rectal cancer NOM.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least 18 years of age
• Biopsy-proven rectal adenocarcinoma of the rectum with clinically suspected or previously known stage I-IIIB (cT1-4, N0-2, M0) disease
• Anticipated or prior chemoradiation as part of an NOM treatment strategy
• Ability to understand and willingness to sign an IRB-approved written informed consent document
Locations
United States
Missouri
Washington University School of Medicine
Saint Louis
Time Frame
Start Date: 2020-06-01
Completion Date: 2022-09-01
Participants
Target number of participants: 14
Treatments
Experimental: FDG PET/MRI
-Patients will undergo FDG-PET/MRI in lieu of the standard pelvic MRI at up to 6 time-points at which it would normally be performed in their care for the period of time extending 30-36 months from the time of enrollment (depending on enrollment point). In the surveillance period, when patients typically undergo pelvic MRI every 3 months, the FDG-PET/MRI will be done in lieu of the standard pelvic MRI on an approximately every-other-scan basis. In other words, the FDG-PET/MRI will occur roughly once every 6 months.
Authors
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine