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.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's enrollment of 15 is below the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Andrei Iagaru is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Jul 2021, 29 months.
Results were first posted in Apr 2025, 3 years 8 months after primary completion.
Of 42 non-industry phase 2 interventional studies under Smoking Cessation, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 61. This study's 29 months is below that.
Counting every sponsor, half of 51 studies reached it within 35 months; a quarter within 14 and three quarters within 60.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Florilglutamic acid f-18
Andrei Iagaru