Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this study is to examine critical aspects of radiation exposure, dose delivery, and systemic yttrium-90 (Y90) exposure related to the infusion of Y90 microspheres for treatment of hepatocellular carcinoma (HCC) and other metastatic liver disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All patients undergoing Y90 radioembolization therapy with SIR-Spheres or TheraSpheres are eligible to participate in this study
• Must be able to schedule and tolerate additional PET/CT imaging following therapy
• Must be able to tolerate additional blood draws before, during, and after the radioembolization therapy procedure.
Locations
United States
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Contact Information
Primary
Dustin Osborne, PhD
dosborne@utmck.edu
8653058264
Backup
Shelley Acuff
sacuff@utmck.edu
8653056312
Time Frame
Start Date: 2018-06-19
Estimated Completion Date: 2019-12-31
Participants
Target number of participants: 20
Treatments
Experimental: SIR-Spheres Therapy Selection
Patient selected for SIR-spheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging.
Experimental: TheraSpheres Therapy Selection
Patient selected for TheraSpheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging.
Related Therapeutic Areas
Sponsors
Collaborators: Biocompatibles UK Ltd
Leads: University of Tennessee