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

December 8, 2021 updated by: Andrei Iagaru, Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Procedure: Computed Tomography (CT)
As part of PET/CT and SPECT/CT scans.
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • tomography
  • X-ray
  • CT SCAN
  • Computed Tomography
Procedure: Positron Emission Tomography (PET)
As part of PET/CT scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PET SCAN
  • Positron Emission Tomography
Device: 90-Yttrium (Y-90) Glass Microspheres
Radiolabel for PET/CT scan
Other Names:
  • TheraSphere
Diagnostic test: Technetium 99mTc albumin aggregated (99mTc-MAA)
Radiolabel for 99mTc-MAA SPECT/CT Scan
Other Names:
  • 99mTc-MAA
Procedure: Single-photon emission computerized tomography (SPECT) scan
As part of SPECT/CT scan
Other Names:
  • SPECT Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality for 90-Y PET/CT Scans
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Andrei Iagaru, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-39332
  • NCI-2017-00463 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • VAR0147 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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