Back to resultsYttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors
Primary Purpose
Primary Malignant Liver Neoplasm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography (CT)
Positron Emission Tomography (PET)
90-Yttrium (Y-90) Glass Microspheres
Technetium 99mTc albumin aggregated (99mTc-MAA)
Single-photon emission computerized tomography (SPECT) scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Malignant Liver Neoplasm
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Arm Description
All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03109262
Brief Title
Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors
Official Title
High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Malignant Liver Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Arm Type
Experimental
Arm Description
All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography (CT)
Other Intervention Name(s)
CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography, X-ray
Intervention Description
As part of PET/CT and SPECT/CT scans.
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
As part of PET/CT scan
Intervention Type
Device
Intervention Name(s)
90-Yttrium (Y-90) Glass Microspheres
Other Intervention Name(s)
TheraSphere
Intervention Description
Radiolabel for PET/CT scan
Intervention Type
Diagnostic Test
Intervention Name(s)
Technetium 99mTc albumin aggregated (99mTc-MAA)
Other Intervention Name(s)
99mTc-MAA
Intervention Description
Radiolabel for 99mTc-MAA SPECT/CT Scan
Intervention Type
Procedure
Intervention Name(s)
Single-photon emission computerized tomography (SPECT) scan
Other Intervention Name(s)
SPECT Scan
Intervention Description
As part of SPECT/CT scan
Primary Outcome Measure Information:
Title
Image Quality for 90-Y PET/CT Scans
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Iagaru
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33443618
Citation
Duan H, Khalaf MH, Ferri V, Baratto L, Srinivas SM, Sze DY, Iagaru A. High quality imaging and dosimetry for yttrium-90 (90Y) liver radioembolization using a SiPM-based PET/CT scanner. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2426-2436. doi: 10.1007/s00259-021-05188-4. Epub 2021 Jan 14.
Results Reference
result
Learn more about this trial
Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors
We'll reach out to this number within 24 hrs