Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization

March 1, 2018 updated by: Washington University School of Medicine

Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization

The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant must successfully complete the MRI screening form if receiving an MRI
  • Participant must be scheduled to undergo radioembolization for any indication
  • Participant must be ≥ 18 years of age
  • Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria:

  • Participant must not have any contraindications to MRI scanning
  • Patient must not be pregnant or breastfeeding
  • If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured within the past 60 days
  • If agreeing to MRI contrast, participant must not be on dialysis
  • If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
  • PET/MRI or PET/CT is not able to be scheduled within 72 hours of radioembolization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PET/MR or PET/CT
  • Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT
  • Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver
Device: PET/CT
Device: PET/MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
Time Frame: 1 day (one time event for patient)
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.
1 day (one time event for patient)
Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization
Time Frame: 1 day (one time event for patient)
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine whether technical success of the procedure can be determined. They will rate the images if they are 'adequate' to report on these two measures.
1 day (one time event for patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2012

Primary Completion (Actual)

April 3, 2017

Study Completion (Actual)

April 3, 2017

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201209062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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