Clinical trial · Interventional
18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cigarette Smoker | — | UNRESOLVED | — |
| Current Smoker | — | UNRESOLVED | — |
| Former Smoker | — | UNRESOLVED | — |
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
| Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Diagnostic Test | — | UNRESOLVED |
| Fludeoxyglucose F-18 | Drug | — | UNRESOLVED |
| Fluorine F 18 L-glutamate Derivative BAY94-9392 | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET/CT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
- description
- 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.
- interventionNames
- Diagnostic Test: Computed Tomography
- Drug: Fludeoxyglucose F-18
- Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
- Diagnostic Test: Positron Emission Tomography (PET/CT)
Primary outcomes (1)
- measure
- Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules
- timeFrame
- Through study completion, an average of 2 years and 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available