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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744054
Recruitment Status : Terminated (Logistics regarding PET/CT portion of study)
First Posted : December 6, 2012
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date March 5, 2018
Actual Study Start Date  ICMJE October 25, 2012
Actual Primary Completion Date April 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • Evaluate y90-PET/MRI for its potential on reporting presence of extrahepatic deposition of microspheres [ Time Frame: 2 years ]
    An MR 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 for its potential on reporting technical success of radioembolization [ Time Frame: 2 years ]
    An MR 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
Official Title  ICMJE Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Liver Neoplasms
Intervention  ICMJE
  • Device: PET/MR
  • Device: PET/CT
Study Arms  ICMJE 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
Interventions:
  • Device: PET/MR
  • Device: PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 1, 2018)
57
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
20
Actual Study Completion Date  ICMJE April 3, 2017
Actual Primary Completion Date April 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744054
Other Study ID Numbers  ICMJE 201209062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP