Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors

Not Applicable

Completed

Interventions: Procedure: Computed Tomography (CT)
Procedure: Positron Emission Tomography (PET)
Device: 90-Yttrium (Y-90) Glass Microspheres
Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA)
Procedure: Single-photon emission computerized tomography (SPECT) scan

Brief Summary: This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.

Detailed Description: PRIMARY OBJECTIVES:

I. To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT.

SECONDARY OBJECTIVES:

I. To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.

OUTLINE:

Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes.

This study compares the experimental images to the regular medical care images in the same participant.

Recruitment & Eligibility

Inclusion Criteria

Patient provides written informed consent
Patient is referred for 90Y SIRT radioembolization of liver tumor(s)
Patient is capable of complying with study procedures
Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans	Single-photon emission computerized tomography (SPECT) scan	All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans	90-Yttrium (Y-90) Glass Microspheres	All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans	Technetium 99mTc albumin aggregated (99mTc-MAA)	All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans	Positron Emission Tomography (PET)	All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans	Computed Tomography (CT)	All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Primary Outcome Measures

Name	Time	Method
Image Quality for 90-Y PET/CT Scans	1 day	Image quality for 90Y PET/CT scan images was assessed relative to the expected image quality of Standard of Care (SoC) 99mTc-MAA SPECT/CT scans obtained from the same participant. Assessments were conducted at 5, 10, 15 and 20 minutes after infusion. Scans were assessed on a 1 to 5 Likert scale by 2 Nuclear Medicine physicians who were blinded to patient information. The Likert scale for image quality was established as follows: 1. = Non-diagnostic 2. = Suboptimal 3. = Acceptable 4. = Good 5. = Excellent, equivalent to a SoC 99mTc-MAA SPECT/CT scan The scans for each individual participant at each timepoint was scored on the Likert scale, as determined by the 2 Nuclear Medicine physicians. The outcome is reported as the overall mean of the physician determinations for each time point, with standard deviation.

Secondary Outcome Measures

Name	Time	Method
Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans	1 day	Radiopharmaceutical dosimetry was assessed based on the numerical tumor-absorbed dose value in Gray as calculated by SurePlan (MIM Software Inc, Cleveland, Ohio). The outcome is reported as the median tumor-absorbed dose in Gray for each scan method (90Y PET/CT and 99mTc-MAA SPECT/CT), with standard deviation.