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

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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

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.

Condition or disease Intervention/treatment Phase
Liver Neoplasms Device: PET/MR Device: PET/CT Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
Actual Study Start Date : October 25, 2012
Actual Primary Completion Date : April 3, 2017
Actual Study Completion Date : April 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Arm Intervention/treatment
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/MR Device: PET/CT



Primary Outcome Measures :
  1. 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.

  2. 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.



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

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): NCT01744054


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01744054     History of Changes
Other Study ID Numbers: 201209062
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases