Trial Outcomes & Findings for 18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules (NCT NCT02448225)
NCT ID: NCT02448225
Last Updated: 2022-10-19
Results Overview
Sensitivity, specificity, overall accuracy and receiver operating characteristic (ROC) curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among analyzed patients. Area under the curve(AUC) is the area under the ROC curve, which is the plot of sensitivity by 1-specificity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2022-10-19
Participant Flow
This study enrolled 46 patients between two clinical sites (15 at Veterans Affairs-Tennessee Valley Health System Nashville, TN and 31 at Vanderbilt University Medical Center, Nashville, TN). The enrollment period was 6/16/15 to 1/5/21.
Participant milestones
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Did not get FSPG scan
|
18
|
|
Overall Study
Treated between the FDG and FSPG scan
|
1
|
Baseline Characteristics
18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
Baseline characteristics by cohort
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
n=46 Participants
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Patients analyzed among enrolled patients
Sensitivity, specificity, overall accuracy and receiver operating characteristic (ROC) curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among analyzed patients. Area under the curve(AUC) is the area under the ROC curve, which is the plot of sensitivity by 1-specificity.
Outcome measures
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
n=26 Participants
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
Cancer Patients
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
|
|---|---|---|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
FDG sensitivity(low and high)
|
0.706 proportion, range 0 to 1, higher better
Interval 0.489 to 0.922
|
—
|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
FDG specificity
|
0.778 proportion, range 0 to 1, higher better
Interval 0.506 to 1.0
|
—
|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
FDG accuracy
|
0.731 proportion, range 0 to 1, higher better
Interval 0.56 to 0.901
|
—
|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
FDG AUC(area under curve)
|
0.817 proportion, range 0 to 1, higher better
Interval 0.653 to 0.981
|
—
|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
ESPG sensitivity(low and high)
|
0.824 proportion, range 0 to 1, higher better
Interval 0.642 to 1.0
|
—
|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
ESPG specificity(low and high)
|
0.667 proportion, range 0 to 1, higher better
Interval 0.359 to 0.975
|
—
|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
ESPG accuracy
|
0.769 proportion, range 0 to 1, higher better
Interval 0.607 to 0.931
|
—
|
|
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
ESPG AUC
|
0.843 proportion, range 0 to 1, higher better
Interval 0.682 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 12 cancer patients among those enrolled.
The level of expression of xCT and CD44 proteins in the cytoplasmic membrane of tumor cells were examined by an experienced pathologist who was blinded to any patient and imaging information. The percentage of tumor cells positive for the marker and the intensity of staining were evaluated, the latter using a scale of 0 (none), 1+ (weak), 2+ (intermediate), and 3+ (strong) with a sample being reported as positive if greater than 10% of the tumor cells in the sample were positively stained with any intensity.
Outcome measures
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
n=12 Participants
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
Cancer Patients
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
|
|---|---|---|
|
CD44 and xC- Expression Levels in Tissue Samples(0-3)
CD44
|
2.6 IHC score, range 0 and above
Standard Deviation 0.5
|
—
|
|
CD44 and xC- Expression Levels in Tissue Samples(0-3)
xCT
|
1 IHC score, range 0 and above
Standard Deviation 1
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: enrolled patients included 7 benign and 19 cancer patients.
Maximum standardized uptake values (SUVmax) were normalized to lean body mass and measured with a 1 cm diameter round region of interest over the area of greatest uptake in the lesion being measured.
Outcome measures
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
n=9 Participants
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
Cancer Patients
n=17 Participants
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
|
|---|---|---|
|
Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor)
|
0.8 Maximum standardized uptake values (SUVm
Standard Deviation 0.7
|
3.9 Maximum standardized uptake values (SUVm
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Cancer patients enrolled.
Sensitivity, specificity, overall accuracy and ROC curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of the biodistribution characteristics of 18F-FDG and 18F-FSPG tests. Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among all patients. Area under the curve(AUC) is the area under the ROC curve.
Outcome measures
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
n=17 Participants
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
Cancer Patients
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
|
|---|---|---|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FDG sensitivity
|
0.8 proportion, range 0-1, higher better
Interval 0.552 to 1.0
|
—
|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FDG specificity
|
0.857 proportion, range 0-1, higher better
Interval 0.598 to 1.0
|
—
|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FDG accuracy
|
0.824 proportion, range 0-1, higher better
Interval 0.642 to 1.0
|
—
|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FDG AUC
|
0.871 proportion, range 0-1, higher better
Interval 0.7 to 1.0
|
—
|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FSPG sensitivity
|
0.2 proportion, range 0-1, higher better
Interval 0.0 to 0.448
|
—
|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FSPG specificity
|
0.286 proportion, range 0-1, higher better
Interval 0.0 to 0.62
|
—
|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FSPG accuracy
|
0.235 proportion, range 0-1, higher better
Interval 0.034 to 0.437
|
—
|
|
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
FSPG AUC
|
0.8 proportion, range 0-1, higher better
Interval 0.594 to 1.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsDescriptive statistics, including means, standard deviations, and ranges for continuous
Outcome measures
Outcome data not reported
Adverse Events
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
n=46 participants at risk
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
1/46 • Number of events 1 • From study entry to approximately 60 days
|
Other adverse events
| Measure |
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
n=46 participants at risk
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Computed Tomography: Undergo 18F-FDG PET/CT - standard of care
Computed Tomography: Undergo 18F-FSPG PET/CT
fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care
Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT
|
|---|---|
|
General disorders
Non-cardiac chest pain
|
8.7%
4/46 • Number of events 5 • From study entry to approximately 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
4/46 • Number of events 4 • From study entry to approximately 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place