Trial Outcomes & Findings for Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer (NCT NCT03463889)
NCT ID: NCT03463889
Last Updated: 2021-06-29
Results Overview
The number of 68Ga PSMA-11 PET-positive lesions detected by staging scans will be descriptively reported.
TERMINATED
PHASE2
12 participants
Up to 24 months
2021-06-29
Participant Flow
Participant milestones
| Measure |
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11: Given IV
Magnetic Resonance Imaging: Undergo MRI in combination with PET
Positron Emission Tomography (PET): Undergo PET in combination with MRI
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
n=12 Participants
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11: Given IV
Magnetic Resonance Imaging: Undergo MRI in combination with PET
Positron Emission Tomography (PET): Undergo PET in combination with MRI
|
|---|---|
|
Age, Customized
40-49 years old
|
2 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
2 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
|
4 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
|
3 Participants
n=5 Participants
|
|
Age, Customized
80-89 years old
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Years from initial diagnosis to study imaging
|
3 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing \[68Ga\]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability
The number of 68Ga PSMA-11 PET-positive lesions detected by staging scans will be descriptively reported.
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
n=11 Participants
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11: Given IV
Magnetic Resonance Imaging: Undergo MRI in combination with PET
Positron Emission Tomography (PET): Undergo PET in combination with MRI
|
|---|---|
|
Number of 68Ga PSMA-11 PET-positive Lesions
|
28 lesions
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing \[68Ga\]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability
The number of overall thyroid cancer lesions detected by standard staging scans will be descriptively reported
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
n=11 Participants
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11: Given IV
Magnetic Resonance Imaging: Undergo MRI in combination with PET
Positron Emission Tomography (PET): Undergo PET in combination with MRI
|
|---|---|
|
Number of Overall Detected Thyroid Cancer Lesions
|
43 lesions
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing \[68Ga\]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability
The mean and standard deviation for SUVmax across all lesions across all patients will be reported.
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
n=11 Participants
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11: Given IV
Magnetic Resonance Imaging: Undergo MRI in combination with PET
Positron Emission Tomography (PET): Undergo PET in combination with MRI
|
|---|---|
|
Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax)
|
8.5 Ratio
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing \[68Ga\]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability
For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true positive rate will be calculated.
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
n=11 Participants
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11: Given IV
Magnetic Resonance Imaging: Undergo MRI in combination with PET
Positron Emission Tomography (PET): Undergo PET in combination with MRI
|
|---|---|
|
Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers
|
.65 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing \[68Ga\]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability
Specificity is the agents ability to exclude the disease when the disease is absent. For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true negative rate will be reported.
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
n=11 Participants
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11: Given IV
Magnetic Resonance Imaging: Undergo MRI in combination with PET
Positron Emission Tomography (PET): Undergo PET in combination with MRI
|
|---|---|
|
Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers
|
1.00 proportion of participants
|
Adverse Events
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Flavell, MD PhD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place