Recruiting

Y90

Sponsor:

University of Tennessee

Code:

NCT03686709

Conditions

Hepatocellular Carcinoma

Radiation Exposure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Post therapy PET/CT Imaging

Study Details

Brief summary:

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.

Conditions

Hepatocellular Carcinoma

Radiation Exposure

Study ID

NCT03686709

Start date

Jun 19, 2018

Status verified date

Jun, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Jun 18, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Post therapy PET/CT Imaging

whole-body PET/CT following Y90 radioembolization

Primary outcome measure

  • Feasibility of Active Dose Delivery Monitoring [ Time Frame: During therapy delivery: ~30 minutes ]
  • 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 ]
  • Therapy Monitoring Using Whole-Body Post-therapy PET/CT Imaging [ Time Frame: Following Y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy ]

Central Contacts and Locations

Central contacts

Dustin Osborne, PhD

8653058264dosborne@utmck.edu

Shelley Acuff

8653056312sacuff@utmck.edu

Locations

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Melissa Weaver

865-305-6181mweaver@utmck.edu

Shelley Acuff

8653056312sacuff@utmck.edu

Principal Investigator:

Dustin Osborne, PhD

More Information

Sponsor

University of Tennessee

Last update posted

Sep 27, 2018

Last verified

Jun, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee on 2018-09-27.