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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization

Conditions
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Liver Neoplasms

Intervention / Treatment
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* Device: PET/MR
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PET/MR or PET/CT<br>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<br> <br> Device: PET/CT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |