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

Primary Purpose

Liver Neoplasms

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PET/MR
PET/CT
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET/MR or PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.
Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization
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.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2012
Last Updated
March 1, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01744054
Brief Title
Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
Official Title
Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Logistics regarding PET/CT portion of study
Study Start Date
October 25, 2012 (Actual)
Primary Completion Date
April 3, 2017 (Actual)
Study Completion Date
April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/MR or PET/CT
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
PET/MR
Intervention Type
Device
Intervention Name(s)
PET/CT
Primary Outcome Measure Information:
Title
Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
Description
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.
Time Frame
1 day (one time event for patient)
Title
Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization
Description
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.
Time Frame
1 day (one time event for patient)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parag Parikh, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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

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