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Brachytherapy
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
N/A
Recruiting
Led By Dustin Osborne, PhD
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy
Awards & highlights
No Placebo-Only Group
Summary
This trial involves injecting tiny radioactive beads into the liver to treat liver cancer. It targets patients with liver cancer who may not respond to other treatments. The beads release radiation that kills cancer cells directly in the liver. This method has been developed as a treatment for liver tumors, delivering high levels of local radiation to the tumor site.
Eligible Conditions
- Liver Cancer
- Nuclear Radiation Emergency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of Active Dose Delivery Monitoring
Measurement and Assessment of Free, Circulating Yttrium 90
Therapy Monitoring Using Whole-Body Post-therapy PET/CT Imaging
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: TheraSpheres Therapy SelectionExperimental Treatment1 Intervention
Patient selected for TheraSpheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging.
Group II: SIR-Spheres Therapy SelectionExperimental Treatment1 Intervention
Patient selected for SIR-spheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging.
Find a Location
Who is running the clinical trial?
University of TennesseeLead Sponsor
196 Previous Clinical Trials
144,833 Total Patients Enrolled
Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,509 Total Patients Enrolled
Dustin Osborne, PhDPrincipal InvestigatorUniversity of Tennessee
1 Previous Clinical Trials
2 Total Patients Enrolled
Christopher Stephens, MDPrincipal InvestigatorUniversity of Tennessee