Clinical Trial: Yttrium Y 90 Glass Microspheres PET/CT in Imaging Patients With Liver Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: This clinical trial studies how well yttrium Y 90 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 yttrium Y 90 glass microspheres, delivered for selective internal radiation therapy (SIRT) compared to the technetium Tc-99m albumin aggregated single photon emission computed tomography (SPECT)/CT images.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To evaluate the image quality of yttrium Y 90 glass microspheres (90Y) 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 90Y PET/CT post SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.

OUTLINE:

Immediately after standard of care SIRT, patients receive yttrium Y 90 glass microspheres and undergo PET/CT over 30 minutes.


Sponsor: Stanford University

Current Primary Outcome: Image quality of lesions detected with PET/CT assessed by 5-point Likert scale [ Time Frame: Up to 1 month ]

Will be compared with the image quality of the lesions seen on the standard of care pre-therapy 99mTc-MAA SPECT/CT.


Original Primary Outcome: Same as current

Current Secondary Outcome: Radiopharmaceutical distribution and dosimetry accuracy of 90Y PET/CT [ Time Frame: Up to 1 month ]

Will compare visual distribution discrepancies (if any) and numerical values calculated by SurePlan from both 99mTc MAA SPECT/CT and 90Y PET/CT images. Will use SurePlan software to edge-contour and calculate tumor radiation absorbed dose values in both 99mTc MAA SPECT/CT and 90Y PET/CT images. This software will convert counts/pixel on the images to radiation absorbed dose measure in gray.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: April 6, 2017
Date Started: February 15, 2017
Date Completion: February 15, 2020
Last Updated: April 6, 2017
Last Verified: April 2017