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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03109262
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arm: 1
• Actual Duration (Months): 48.4
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Malignant Liver Neoplasm	Procedure: Computed Tomography (CT); Procedure: Positron Emission Tomography (PET); Device: 90-Yttrium (Y-90) Glass Microspheres; Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA); Procedure: Single-photon emission computerized tomography (SPECT) scan	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT
• Actual Study Start Date: Feb 15, 2017
• Actual Primary Completion Date: May 30, 2019
• Actual Study Completion Date: Feb 28, 2021

Arms and Interventions

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: CAT CAT Scan Computed Tomography Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography X-ray ; Procedure: Positron Emission Tomography (PET); As part of PET/CT scan; Other Names: Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging ; 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

Outcome Measures

Primary Outcome Measures

1. Image Quality for 90-Y PET/CT Scans [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: = 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

1. Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Andrei Iagaru, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 18, 2017
• Informed Consent Form - Jan 15, 2019

More Information

Publications

None provided.

• Responsible Party: Andrei Iagaru, Professor of Radiology (Nuclear Medicine), Stanford University
• ClinicalTrials.gov Identifier: NCT03109262
• Other Study ID Numbers: IRB-39332; NCI-2017-00463; VAR0147
• First Posted: Apr 12, 2017
• Last Update Posted: Jan 10, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Liver Neoplasms

Study Results

Participant Flow

Arm/Group Title	Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Arm/Group Description	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 Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/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
Period Title: Overall Study
STARTED	42
COMPLETED	42
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Arm/Group Description	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 Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/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
Overall Participants	42
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 38.1%
>=65 years	26 61.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.1 (11.4)
Sex: Female, Male (Count of Participants)
Female	13 31%
Male	29 69%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 9.5%
Not Hispanic or Latino	38 90.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.4%
Asian	13 31%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 4.8%
White	22 52.4%
More than one race	0 0%
Unknown or Not Reported	4 9.5%
Region of Enrollment (participants) [Number]
United States	42 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Arm/Group Description	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 Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/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
Measure Participants	42
5 minutes	3.56 (0.43)
10 minutes	4.63 (0.49)
15 minutes	4.89 (0.28)
20 minutes	4.93 (0.21)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yttrium Y-90 PET/CT	99mTc-MAA SPECT/CT Scans
Arm/Group Description	All participants receive Y-90 PET/CT Scan Computed Tomography (CT): As part of PET/CT scan. Positron Emission Tomography (PET): As part of PET/CT scan 90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan	All participants receive 99mTc-MAA SPECT/CT scan Computed Tomography (CT): As part of SPECT/CT scans. Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan
Measure Participants	42	42
Median (Standard Error) [Gray]	142.9 (99.7)	118.9 (91.0)

Adverse Events

Time Frame	1 day
Arm/Group Title	Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Arm/Group Description	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 Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/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
All Cause Mortality
	Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
	Affected / at Risk (%)	# Events
Total	0/42 (0%)
Serious Adverse Events
	Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
	Affected / at Risk (%)	# Events
Total	0/42 (0%)
Other (Not Including Serious) Adverse Events
	Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
	Affected / at Risk (%)	# Events
Total	0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.