NCT03109262

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Malignant Liver Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography (CT)	As part of PET/CT and SPECT/CT scans.
PROCEDURE	Positron Emission Tomography (PET)	As part of PET/CT scan
DEVICE	90-Yttrium (Y-90) Glass Microspheres	Radiolabel for PET/CT scan
DIAGNOSTIC_TEST	Technetium 99mTc albumin aggregated (99mTc-MAA)	Radiolabel for 99mTc-MAA SPECT/CT Scan
PROCEDURE	Single-photon emission computerized tomography (SPECT) scan	As part of SPECT/CT scan

Timeline

• Start date: 2017-02-15
• Primary completion: 2019-05-30
• Completion: 2021-02-28
• First posted: 2017-04-12
• Last updated: 2022-01-10
• Results posted: 2021-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study