Phase 2
N=15
18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
Cigarette Smoker · Current Smoker · Former Smoker · Multiple Pulmonary Nodules · Pulmonary Nodule
Bottom Line
View on ClinicalTrials.gov: NCT03824535 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules — 100; 70; 100; 100 percentage — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Computed Tomography (Diagnostic_test); Fludeoxyglucose F-18 (Drug); Fluorine F 18 L-glutamate Derivative BAY94-9392 (Drug); Positron Emission Tomography (PET/CT) (Diagnostic_test)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Andrei Iagaru
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules |
100; 70; 100; 100; 100; 100 | 0.02 sig |
| SECONDARY Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC) |
0.84; 1.0 | 0.004 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be eligible if the dominant nodule is 7 to 30 mm
- Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule)
- Current or former cigarette smoker, with >= 20 pack years
- Documented informed consent
Exclusion Criteria
- History or previous diagnosis of lung cancer
- Cancer diagnosis within the last 5 years
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03824535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.