Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
This study is looking at how Yttrium-90 (Y90) radioembolization, a treatment for liver cancer (hepatocellular carcinoma) and other liver diseases, works in the body. Researchers want to understand how the Y90 microspheres (tiny radioactive beads) are delivered, how much radiation staff are exposed to, and how much Y90 circulates in a patient's body. You may be able to join if you are an adult receiving Y90 radioembolization therapy with SIR-Spheres or TheraSpheres, can have extra PET/CT scans (a type of imaging), and can have additional blood draws. The study aims to see if it's possible to actively monitor the dose during treatment, measure circulating Y90, and use whole-body PET/CT imaging to track the therapy. The current status of this study is unclear, and it plans to enroll 20 participants.
- Study design
- This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would need to schedule and tolerate additional PET/CT imaging after therapy, and tolerate extra blood draws before, during, and after the radioembolization procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Monitoring for dose delivery and circulating Y90 occurs during and shortly after therapy (around 30-40 minutes to 2-4 hours post-therapy).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
At a glance
Conditions
NCT03686709
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Tennessee Medical Center
Knoxville, Tennesseestudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Dustin Osborne, PhD · PRINCIPAL_INVESTIGATOR · University of Tennessee
- Christopher Stephens, MD · PRINCIPAL_INVESTIGATOR · University of Tennessee
Who to contact
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Inclusion
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What this trial measures
- Feasibility of Active Dose Delivery MonitoringDuring therapy delivery: ~30 minutes
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.
- Measurement and Assessment of Free, Circulating Yttrium 90Before, during, and after therapy delivery as well as in conjunction with PET/CT: ~40 minutes
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.
- Therapy Monitoring Using Whole-Body Post-therapy PET/CT ImagingFollowing Y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy
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.