Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Tennessee
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients that are not candidates for Y90 radioembolization therapy
Patients that cannot tolerate additional imaging procedures following therapy
Patients that cannot tolerate the additional blood draws required for this study
Patients whose schedule does not allow them to remain at the hospital for the additional PET/CT imaging study
Trial design
Design model
Parallel
Treatments tested in this trial
Post therapy PET/CT Imaging
Diagnostic testwhole-body PET/CT following Y90 radioembolization
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: SIR-Spheres Therapy SelectionExperimental treatment 1 intervention
Group B: TheraSpheres Therapy SelectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Active Dose Delivery Monitoring
This outcome will be measured using modular detector devices placed on the Y90 dose delivery system as well as on the patient. These radiation detectors monitor radiation in real-time during the dose infusion. Time activity curves from the detectors will be collected and assessed for determining if the full dose was delivered as intended.
Time frame
During therapy delivery: ~30 minutes2
Measurement and Assessment of Free, Circulating Yttrium 90
This outcome measure will examine the ability to measure free Y90 in the blood during routine therapy procedures. This outcome will be monitored by both modular radiation detectors placed on the patient as well as through blood samples taken before, during, and after the infusion of the therapy dose. An initial blood draw prior to the delivery of the Y90 therapy will provide a baseline for each patient. Samples taken during and after infusion will provide key insights into the changes in blood radioactivity levels which will correspond to the infusion of Y90 and subsequently, the free Y90 circulating in the blood that was not directed to the tumor.
Time frame
Before, during, and after therapy delivery as well as in conjunction with PET/CT: ~40 minutes3
Therapy Monitoring Using Whole-Body Post-therapy PET/CT Imaging
This outcome measure will examine the final treatment biodistribution using PET/CT imaging for visual analysis of the data to assess the distribution of spheres within the site of delivery.
Time frame
Following Y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Tennessee
Lead sponsor
Biocompatibles UK Ltd
Collaborator
Source ClinicalTrials.gov