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

Study Overview
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Brief Summary
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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
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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.

Official Title
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High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT

Conditions
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Primary Malignant Liver Neoplasm

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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: Patient is pregnant or nursing

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 |
| --- | --- |
| Experimental: Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans<br>All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Procedure: Computed Tomography (CT)<br>* As part of PET/CT and SPECT/CT scans.<br>* Other names: X-ray;Procedure: Positron Emission Tomography (PET)<br>* As part of PET/CT scan<br>* Other names: proton magnetic resonance spectroscopic imaging;Device: 90-Yttrium (Y-90) Glass Microspheres<br>* Radiolabel for PET/CT scan<br>* Other names: TheraSphere;Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA)<br>* Radiolabel for 99mTc-MAA SPECT/CT Scan<br>* Other names: 99mTc-MAA;Procedure: Single-photon emission computerized tomography (SPECT) scan<br>* As part of SPECT/CT scan<br>* Other names: SPECT Scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality for 90-Y PET/CT Scans | 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: = Non-diagnostic = Suboptimal = Acceptable = Good = 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans | 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. | 1 day |