Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment

NCT03686709 | Recruiting FDA Device

• 1 other identifier: 4388
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of Active Dose Delivery Monitoring

  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.

  During therapy delivery: ~30 minutes

• Measurement and Assessment of Free, Circulating Yttrium 90

  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.

  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

  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.

  Following Y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy

Study Arms (2)

SIR-Spheres Therapy Selection

EXPERIMENTAL

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.

Diagnostic Test: Post therapy PET/CT Imaging

TheraSpheres Therapy Selection

EXPERIMENTAL

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.

Diagnostic Test: Post therapy PET/CT Imaging

Interventions

Post therapy PET/CT Imaging DIAGNOSTIC_TEST

whole-body PET/CT following Y90 radioembolization

SIR-Spheres Therapy Selection; TheraSpheres Therapy Selection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Dustin Osborne, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Christopher Stephens, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dustin Osborne, PhD

CONTACT

8653058264; dosborne@utmck.edu

Shelley Acuff

CONTACT

8653056312; sacuff@utmck.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasibility study assessing radiation exposure and distribution of Y90 therapy agents. Two groups of 10 patients will be recruited with equal numbers in each group for each of the two types of Y90 radioembolization products commercially available in the United States.Both groups undergo the same monitoring procedures throughout the study and then will be compared. Stratification of patients into therapy groups is solely based on clinical standard of care decision making.

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: September 27, 2018
• Study Start: June 19, 2018
• Primary Completion: June 18, 2019
• Study Completion: December 31, 2019
• Last Updated: September 27, 2018

Record last verified: 2018-06

Locations

US (1)