Trial Outcomes & Findings for Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors (NCT NCT03109262)
NCT ID: NCT03109262
Last Updated: 2022-01-10
Results Overview
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.
COMPLETED
NA
42 participants
1 day
2022-01-10
Participant Flow
Participant milestones
| Measure |
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
* 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 Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors
Baseline characteristics by cohort
| Measure |
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
n=42 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=99 Participants
|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 dayImage 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.
Outcome measures
| Measure |
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
n=42 Participants
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
|
99mTc-MAA SPECT/CT Scans
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
|
|---|---|---|
|
Image Quality for 90-Y PET/CT Scans
5 minutes
|
3.56 units on a scale
Standard Deviation 0.43
|
—
|
|
Image Quality for 90-Y PET/CT Scans
10 minutes
|
4.63 units on a scale
Standard Deviation 0.49
|
—
|
|
Image Quality for 90-Y PET/CT Scans
15 minutes
|
4.89 units on a scale
Standard Deviation 0.28
|
—
|
|
Image Quality for 90-Y PET/CT Scans
20 minutes
|
4.93 units on a scale
Standard Deviation 0.21
|
—
|
SECONDARY outcome
Timeframe: 1 dayRadiopharmaceutical 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.
Outcome measures
| Measure |
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
n=42 Participants
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
|
99mTc-MAA SPECT/CT Scans
n=42 Participants
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
|
|---|---|---|
|
Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
|
142.9 Gray
Standard Error 99.7
|
118.9 Gray
Standard Error 91.0
|
Adverse Events
Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrei Iagaru, PROFESSOR OF RADIOLOGY (NUCLEAR MEDICINE)
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place