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Trial record 35 of 46 for:    SIR-Spheres

Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment

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ClinicalTrials.gov Identifier: NCT03686709
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
University of Tennessee

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation Exposure Diagnostic Test: Post therapy PET/CT Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 18, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Diagnostic Test: Post therapy PET/CT Imaging
whole-body PET/CT following Y90 radioembolization

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.
Diagnostic Test: Post therapy PET/CT Imaging
whole-body PET/CT following Y90 radioembolization




Primary Outcome Measures :
  1. Feasibility of Active Dose Delivery Monitoring [ Time Frame: During therapy delivery: ~30 minutes ]
    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.

  2. 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 ]
    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.

  3. Therapy Monitoring Using Whole-Body Post-therapy PET/CT Imaging [ Time Frame: Following Y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686709


Contacts
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Contact: Dustin Osborne, PhD 8653058264 dosborne@utmck.edu
Contact: Shelley Acuff 8653056312 sacuff@utmck.edu

Locations
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United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Melissa Weaver    865-305-6181    mweaver@utmck.edu   
Contact: Shelley Acuff    8653056312    sacuff@utmck.edu   
Principal Investigator: Dustin Osborne, PhD         
Principal Investigator: Christopher Stephens, MD         
Sponsors and Collaborators
University of Tennessee
Biocompatibles UK Ltd
Investigators
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Principal Investigator: Dustin Osborne, PhD University of Tennessee
Principal Investigator: Christopher Stephens, MD University of Tennessee

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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT03686709     History of Changes
Other Study ID Numbers: 4388
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data currently will not be shared but could potentially be shared in the future.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases