45 and older, any sex, with Cigarette Smoker or Current Smoker. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung NodulesPrimary· Through study completion, an average of 2 years and 6 months
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 t
Sensitivity
Group
Value
95% CI
Diagnostic (18F-FSPG PET/CT)
100
100 – 100
Diagnostic (18F-FDG PET/CT)
70
35 – 93
Specificity
Group
Value
95% CI
Diagnostic (18F-FSPG PET/CT)
100
40 – 100
Diagnostic (18F-FDG PET/CT)
100
40 – 100
Positive Predictive Value (PPV)
Group
Value
95% CI
Diagnostic (18F-FSPG PET/CT)
100
100 – 100
Diagnostic (18F-FDG PET/CT)
100
100 – 100
Negative Predictive Value (NPV)
Group
Value
95% CI
Diagnostic (18F-FSPG PET/CT)
100
100 – 100
Diagnostic (18F-FDG PET/CT)
57
34 – 77
Accuracy
Group
Value
95% CI
Diagnostic (18F-FSPG PET/CT)
100
77 – 100
Diagnostic (18F-FDG PET/CT)
79
49 – 95
Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC)Secondary· 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.
Group
Value
95% CI
Baseline Diagnostic (18F-FSPG PET/CT)
0.84
± 0.1
Improved Diagnostic (18F-FDG PET/CT)
1.0
± 0.0
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Andrei Iagaru
Last refreshed: 9 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03824535.