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

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.

• Computed Tomography (CT) (Procedure), also known as CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography, X-ray: As part of PET/CT and SPECT/CT scans.
• Positron Emission Tomography (PET) (Procedure), also known as Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging: As part of PET/CT scan
• 90-Yttrium (Y-90) Glass Microspheres (Device), also known as TheraSphere: Radiolabel for PET/CT scan
• Technetium 99mTc albumin aggregated (99mTc-MAA) (Diagnostic test), also known as 99mTc-MAA: Radiolabel for 99mTc-MAA SPECT/CT Scan
• Single-photon emission computerized tomography (SPECT) scan (Procedure), also known as SPECT Scan: As part of SPECT/CT scan

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Image Quality for 90-Y PET/CT Scans (Primary), Mean, units on a scale: Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans 3.56 +/- 0.43
• Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans (Secondary), Median, Gray: Yttrium Y-90 PET/CT 142.9 +/- 99.7; 99mTc-MAA SPECT/CT Scans 118.9 +/- 91.0

Adverse events

Time frame: 1 day

• Results publication: Duan H, Khalaf MH, Ferri V, Baratto L, Srinivas SM, Sze DY, Iagaru A. High quality imaging and dosimetry for yttrium-90 (90Y) liver radioembolization using a SiPM-based PET/CT scanner. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2426-2436. doi: 10.1007/s00259-021-05188-4. Epub 2021 Jan 14. PMID 33443618

• Study Protocol and Statistical Analysis Plan (PDF, 2017-12-18)
• Informed Consent Form (PDF, 2019-01-15)

• Andrei Iagaru, Principal investigator, Stanford University