Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors
NCT ID: NCT03109262
Last Updated: 2022-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2017-02-15
2021-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
Computed Tomography (CT)
As part of PET/CT and SPECT/CT scans.
Positron Emission Tomography (PET)
As part of PET/CT scan
90-Yttrium (Y-90) Glass Microspheres
Radiolabel for PET/CT scan
Technetium 99mTc albumin aggregated (99mTc-MAA)
Radiolabel for 99mTc-MAA SPECT/CT Scan
Single-photon emission computerized tomography (SPECT) scan
As part of SPECT/CT scan
Interventions
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Computed Tomography (CT)
As part of PET/CT and SPECT/CT scans.
Positron Emission Tomography (PET)
As part of PET/CT scan
90-Yttrium (Y-90) Glass Microspheres
Radiolabel for PET/CT scan
Technetium 99mTc albumin aggregated (99mTc-MAA)
Radiolabel for 99mTc-MAA SPECT/CT Scan
Single-photon emission computerized tomography (SPECT) scan
As part of SPECT/CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Principal Investigators
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Andrei Iagaru
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Palo Alto, California, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-00463
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAR0147
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-39332
Identifier Type: -
Identifier Source: org_study_id
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