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

Primary Malignant Liver Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109262
• Other study ID #: IRB-39332
• Secondary ID: NCI-2017-00463VA
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: December 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 28, 2021
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Primary Malignant Liver Neoplasm

Intervention

Procedure:
• Computed Tomography (CT)
As part of PET/CT and SPECT/CT scans.
• 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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Duan H, Khalaf MH, Ferri V, Baratto L, Srinivas SM, Sze DY, Iagaru A. High quality imaging and dosimetry for yttrium-90 ((90)Y) liver radioembolization using a SiPM-based PET/CT scanner. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2426-2436. doi: 10.1007/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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