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

The Washington University

Status and phase: Terminated; Phase 1

Conditions: Liver Neoplasms

Treatments: Device: PET/CT; Device: PET/MR

Study type: Interventional

Funder types: Other

Identifiers

NCT01744054

201209062

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

PET/MR or PET/CT

Other group

Description:

* 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

Treatment:

Device: PET/CT

Device: PET/MR