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Microsphere Localization Using PET/MRI in Patients With Liver Disease

This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01744054
First received: November 30, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

To evaluate y90-PET/MRI (Positron Emission Tomography / Magnetic Resonance Imaging) for its potential on reporting 1) technical success of radioembolization and 2) presence of extrahepatic deposition of microspheres


Condition Intervention
Liver Neoplasms
 Other: PET MRI with or without contrast post Radioembolization

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study of Microsphere Localization Using PET/MRI in Patients With Liver Disease Following Radioembolization

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Evaluate y90-PET/MRI for its potential on reporting presence of extrahepatic deposition of microspheres [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PET MRI
Radioembolization, within 72 hours PET/MRI with or without contrast
 Other: PET MRI with or without contrast post Radioembolization
Radioembolization, within 72 hours PET/MRI with or without contrast

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must successfully complete the MRI screening form
  • Participant must be scheduled to undergo radioembolization for liver disease
  • 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 is not able to be scheduled within 72 hours of radioembolization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744054

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

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63122
Contact: Parag Parikh, M.D.     314-747-9614     pparikh@radonc.wustl.edu    
Sub-Investigator: Ananya Benegal            
Sub-Investigator: Akash Sharma, M.D.            
Sub-Investigator: Jeff Olsen, M.D.            
Sub-Investigator: Kathryn Fowler, M.D.            
Sub-Investigator: Richard LaForest, PhD            
Sub-Investigator: Jose Garcia-Ramirez, M.S            
Sub-Investigator: Seth Klein, M.D.            
Sub-Investigator: Nael Saad, M.D.            
Sub-Investigator: Darryl Zuckerman, 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:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01744054     History of Changes
Other Study ID Numbers: 201209062
Study First Received: November 30, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Liver Diseases
Liver Neoplasms
 Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 21, 2013