Assessing radiation exposure and dose delivery in Y90 radioembolization for liver cancer
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
This study is testing how much radiation doctors and nurses are exposed to while using a new treatment for liver cancer that involves tiny radioactive beads, to make sure everyone stays safe during the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Tennessee Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT03686709 on ClinicalTrials.gov |
What this trial studies
This study investigates the radiation exposure and dose delivery associated with the use of yttrium-90 (Y90) microspheres in treating hepatocellular carcinoma (HCC) and other metastatic liver diseases. It focuses on the safety of clinical personnel handling these radioactive materials and employs advanced dosimeter technology to measure radiation exposure. Additionally, the study will utilize a portable detector for real-time monitoring of radiation fields during the administration of Y90 microspheres. The findings aim to enhance the understanding of safety protocols and improve treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing Y90 radioembolization therapy with SIR-Spheres or TheraSpheres who can tolerate additional imaging and blood draws.
Not a fit: Patients who are not candidates for Y90 radioembolization therapy or cannot tolerate additional imaging or blood draws will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve safety protocols for healthcare workers and enhance the effectiveness of Y90 radioembolization therapy for patients with liver cancer.
How similar studies have performed: While there have been studies on radiation exposure in similar contexts, this specific approach using new dosimeter technology and real-time monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Knoxville, Tennessee
- University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Dustin Osborne, PhD — University of Tennessee
- Study coordinator: Dustin Osborne, PhD
- Email: dosborne@utmck.edu
- Phone: 8653058264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.