NCT03686709 · University of Tennessee
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Post therapy PET/CT Imaging
whole-body PET/CT following Y90 radioembolization
Primary outcome measures
Feasibility of Active Dose Delivery Monitoring
Time frame: During 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 90
Time frame: Before, 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 Imaging
Time frame: Following 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- Knoxville, Tennessee
Collaborators
Biocompatibles UK Ltd
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 27, 2018 · Source of record for eligibility and locations