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

Stanford University

Status: Completed

Conditions: Primary Malignant Liver Neoplasm

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03109262

VAR0147 (Other Identifier)

IRB-39332

NCI-2017-00463 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Experimental group

Description:

All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Treatment:

Device: 90-Yttrium (Y-90) Glass Microspheres

Procedure: Single-photon emission computerized tomography (SPECT) scan

Procedure: Positron Emission Tomography (PET)

Procedure: Computed Tomography (CT)

Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA)