Actively Recruiting
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment for Hepatocellular Carcinoma and Metastatic Liver Disease
Led by University of Tennessee · Updated on 2018-09-27
20
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
U
University of Tennessee
Lead Sponsor
B
Biocompatibles UK Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating radiation exposure, dose delivery, and systemic yttrium-90 (Y90) exposure during Y90 microsphere infusion for hepatocellular carcinoma (HCC) and other metastatic liver diseases. This study focuses on assessing radiation exposure to healthcare staff, real-time monitoring of Y90 dose delivery, and the leaching of free Y90 after treatment. It aims to better understand safety, dose delivery accuracy, and radiation spread within the body. The study involves two patient groups receiving radioembolization therapy with either SIR-Spheres or TheraSpheres Y90 microspheres. During therapy, external detectors monitor radiation at delivery points and on the patient. Blood samples are collected before, during, and after infusion to measure radiation levels. After therapy, patients undergo standard bremsstrahlung SPECT imaging and extended whole-body PET/CT scans to evaluate Y90 distribution and leaching. Participants will be closely monitored through radiation detectors and multiple blood draws, along with imaging assessments including PET/CT scans covering from head to lower extremities. Researchers will analyze dose delivery feasibility, free circulating Y90 levels, and whole-body radiation patterns. The total imaging and monitoring time includes about 30 to 40 minutes during and after therapy, with additional follow-up assessments. This detailed approach helps assess treatment delivery and radiation exposure for patients and staff.
CONDITIONS
Brief Title
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing Y90 radioembolization therapy with SIR-Spheres or TheraSpheres
- Ability to schedule and tolerate additional PET/CT imaging after therapy
- Ability to tolerate additional blood draws before, during, and after radioembolization therapy
You will not qualify if you...
- Not a candidate for Y90 radioembolization therapy
- Unable to tolerate additional imaging after therapy
- Unable to tolerate additional blood draws required for the study
- Schedule does not allow remaining at the hospital for additional PET/CT imaging after therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - ~30 to 40 minutes during therapy delivery
Participants receive Y90 radioembolization therapy with SIR-Spheres or TheraSpheres. Radiation exposure to clinical staff and dose delivery are monitored using external detectors. Blood draws are collected before, during, and after therapy to monitor radiation levels.
1 visit (in-person) for therapy and monitoring
Duration - ~30 to 40 minutes
Participants undergo whole-body PET/CT imaging approximately 2 to 4 hours after therapy to monitor therapy distribution and assess radiation leaching. Additional blood draws are taken in conjunction with the PET/CT imaging.
1 imaging visit (in-person) after therapy
Trial Site Locations
Total: 1 location
1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
D
Dustin Osborne, PhD
S
Shelley Acuff
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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