Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
University of Tennessee
Study ID
NCT03686709
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Post therapy PET/CT Imaging — DIAGNOSTIC_TEST
    whole-body PET/CT following Y90 radioembolization

Study Details

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.

Key Dates

Start date
Jun 19, 2018
Status verified
Jun 2018
Primary completion
Jun 18, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: SIR-Spheres Therapy Selection
    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.
  • Experimental: TheraSpheres Therapy Selection
    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.

Primary Outcome Measure

Feasibility of Active Dose Delivery Monitoring [ Time Frame: During therapy delivery: ~30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Tennessee Medical CenterKnoxvilleTennessee37920
Melissa Weaver
[email protected]
865-305-6181
Shelley Acuff
[email protected]
8653056312
Dustin Osborne, PhD (PRINCIPAL_INVESTIGATOR)
Christopher Stephens, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Knoxville, TN

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Tennessee Medical Center· Knoxville, TN

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