A Phase 2 interventional study of Computed Tomography and Fludeoxyglucose F-18 in Cigarette Smoker, Current Smoker and Former Smoker, sponsored by Andrei Iagaru. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Andrei Iagaru · Phase 2, Interventional, and Diagnostic
This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with indeterminate lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.
PRIMARY OBJECTIVES:
I. Comparison of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) accumulation with fludeoxyglucose F-18 (18F-FDG) accumulation to assess whether (4S)-4-(3-18F-Fluoropropyl)-L-Glutamate (18F-FSPG)-PET is better at discriminating between benign and malignant nodules.
SECONDARY OBJECTIVES:
I. To develop and validate early lung cancer detection biomarkers that would directly impact the growing need to integrate imaging and non-invasive molecular diagnostics for indeterminate pulmonary nodules and allow physicians to avoid unnecessary invasive procedures in patients with benign lung disease.
OUTLINE:
Patients receive 18F-FSPG intravenously (IV) and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG and undergo a second PET/CT scan over 30-60 minutes.
After completion of study, patients are followed up within 24-72 hours.
Exclusion Criteria:
Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes.
Diagnostic Test: Computed Tomography · Drug: Fludeoxyglucose F-18 · Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392 · Diagnostic Test: Positron Emission Tomography (PET/CT)
Undergo PET/CT
Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Given IV
Also known as: 18-FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Given IV
Also known as: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392
Undergo PET/CT
Also known as: Positron Emission Tomography/computer tomography, CT Scan, PET Scan, Positron Emission Tomography, medical imaging
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules
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.
Time frame: Through study completion, an average of 2 years and 6 months
Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC)
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.
Time frame: Through study completion, an average of 2 years and 6 months
| Milestone | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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.
| percentage | Diagnostic (18F-FSPG PET/CT) | Diagnostic (18F-FDG PET/CT) |
|---|---|---|
| Sensitivity | 100 (100 to 100) | 70 (35 to 93) |
| Specificity | 100 (40 to 100) | 100 (40 to 100) |
| Positive Predictive Value (PPV) | 100 (100 to 100) | 100 (100 to 100) |
| Negative Predictive Value (NPV) | 100 (100 to 100) | 57 (34 to 77) |
| Accuracy | 100 (77 to 100) | 79 (49 to 95) |
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.
| probability | Baseline Diagnostic (18F-FSPG PET/CT) | Improved Diagnostic (18F-FDG PET/CT) |
|---|---|---|
| Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC) | 0.84 ± 0.1 | 1.0 ± 0.0 |
Collected over Within 24 to 72hours after the 18F-FSPG PET/CT. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 13 |
| Sex: Female, Male(Participants) | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
|---|---|
| Female | 5 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
|---|---|
| United States | 15 |
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Andrei Iagaru