Trial Outcomes & Findings for 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules (NCT NCT03824535)

Last Updated: 2025-04-09

Results Overview

The diagnostic performance of ultrasonography and capnography in detecting malignant lung nodules was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. Sensitivity and specificity were calculated to determine the ability to correctly identify malignant and non-malignant nodules, respectively. Results were compared to a predefined threshold of 75%, with all percentages reported as proportions of the total number of nodules analyzed. Confidence intervals were calculated for each metric to ensure precision and reliability in the estimates.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Through study completion, an average of 2 years and 6 months

Results posted on

2025-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) n=15 Participants Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 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	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	11 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	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 2 years and 6 months

Population: One lesion per participant was evaluated; therefore, lesion and participant counts match 1:1.

Outcome measures

Outcome measures
Measure	Diagnostic (18F-FSPG PET/CT) n=15 Nodules Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT	Diagnostic (18F-FDG PET/CT) n=15 Nodules Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules Sensitivity	100 percentage Interval 100.0 to 100.0	70 percentage Interval 35.0 to 93.0
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules Specificity	100 percentage Interval 40.0 to 100.0	100 percentage Interval 40.0 to 100.0
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules Positive Predictive Value (PPV)	100 percentage Interval 100.0 to 100.0	100 percentage Interval 100.0 to 100.0
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules Negative Predictive Value (NPV)	100 percentage Interval 100.0 to 100.0	57 percentage Interval 34.0 to 77.0
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules Accuracy	100 percentage Interval 77.0 to 100.0	79 percentage Interval 49.0 to 95.0

SECONDARY outcome

Timeframe: Through study completion, an average of 2 years and 6 months

The predictive accuracy of the lung nodule diagnosis model was assessed using the C statistic, also referred to as the area under the receiver operating characteristic (ROC) curve (AUC). Improved performance was defined as a statistically significant increase (p \< 0.05) in the C statistic, determined using the DeLong test for comparing correlated ROC curves. The Mann-Whitney U test was also used to compare the distributions of the C statistic between diagnostic methods. Results are reported as the mean C statistic with 95% confidence intervals for each diagnostic method.

Outcome measures

Outcome measures
Measure	Diagnostic (18F-FSPG PET/CT) n=15 Nodules Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT	Diagnostic (18F-FDG PET/CT) n=15 Nodules Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT
Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC)	0.84 probability Standard Error 0.1	1.0 probability Standard Error 0.0

Adverse Events

Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carina Mari Aparici

Stanford University

Phone: 650-497 9280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place