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

This study is currently recruiting participants.
Verified April 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744054
First Posted: December 6, 2012
Last Update Posted: May 1, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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 Intervention Phase
Liver Neoplasms Device: PET/MR Device: PET/CT Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Actual Study Start Date: October 25, 2012
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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


Contacts
Contact: Parag Parikh, M.D. 314-747-9614 parikh@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63122
Contact: Parag Parikh, M.D.    314-747-9614    parikh@wustl.edu   
Sub-Investigator: Kathryn Fowler, M.D.         
Sub-Investigator: Richard LaForest, PhD         
Sub-Investigator: Jose Garcia-Ramirez, M.S         
Sub-Investigator: Nael Saad, M.D.         
Sub-Investigator: Todd DeWees, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01744054     History of Changes
Other Study ID Numbers: 201209062
First Submitted: November 30, 2012
First Posted: December 6, 2012
Last Update Posted: May 1, 2017
Last Verified: April 2017
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