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

NCT01744054 | Terminated Phase 1 DMC FDA Device

• 1 other identifier: 201209062
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day (one time event for patient)

• 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.

  1 day (one time event for patient)

Study Arms (1)

PET/MR or PET/CT

OTHER

* 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

Interventions

PET/MR DEVICE

PET/MR or PET/CT

PET/CT DEVICE

PET/MR or PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Parag Parikh, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 6, 2012
• Study Start: October 25, 2012
• Primary Completion: April 3, 2017
• Study Completion: April 3, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)