Cigarette SmokerPhase 2NCT03824535
18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
A Phase 2 study testing Computed Tomography, Fludeoxyglucose F-18 and Fluorine F 18 L-glutamate Derivative BAY94-9392 in people with Cigarette Smoker and Current Smoker, run by Andrei Iagaru at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cigarette Smoker, Current Smoker, Former Smoker
- What is being tested?
- Computed Tomography, Fludeoxyglucose F-18 and Fluorine F 18 L-glutamate Derivative BAY94-9392
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 30 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History or previous diagnosis of lung cancer
- Cancer diagnosis within the last 5 years
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
About this study
Official title: 18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cigarette Smoker, Current Smoker, Former Smoker, Multiple Pulmonary Nodules, Pulmonary Nodule
- Being tested
- Computed Tomography, Fludeoxyglucose F-18, Fluorine F 18 L-glutamate Derivative BAY94-9392, Positron Emission Tomography (PET/CT)
- Keywords
- Indeterminate lung nodule
- Medical subject headings
- Smoking Cessation, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyDiagnostic test
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT
Fludeoxyglucose F-18Drug
Also called 18-FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18
Given IV
Fluorine F 18 L-glutamate Derivative BAY94-9392Drug
Also called (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392
Given IV
Positron Emission Tomography (PET/CT)Diagnostic test
Also called Positron Emission Tomography/computer tomography, CT Scan, PET Scan, Positron Emission Tomography
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) | Experimental | 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. Receives: Diagnostic Test: Computed Tomography; Drug: Fludeoxyglucose F-18; Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392; Diagnostic Test: Positron Emission Tomography (PET/CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years and 6 months
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 2 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start4 Feb 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette SmokerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Collaborators
- Canary Foundation, Boston University, United States Department of Defense
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Carina Mari Aparici, Principal investigator, Stanford Cancer Institute Palo Alto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824535
- Sponsor's protocol ID
- IRB-46607
- Other IDs
- NCI-2019-00177, LUN0106, IRB-46607
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2019
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT03824535
- Acronym / sponsor ID
- IRB-46607
- Conditions
- Cigarette Smoker, Current Smoker, Former Smoker, Multiple Pulmonary Nodules, Pulmonary Nodule
- Keywords
- Indeterminate lung nodule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- Collaborators
- Canary Foundation, Boston University, United States Department of Defense
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) | Experimental | Diagnostic Test: Computed Tomography, Drug: Fludeoxyglucose F-18, Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392, Diagnostic Test: Positron Emission Tomography (PET/CT)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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History or previous diagnosis of lung cancer
- Cancer diagnosis within the last 5 years
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET/CT | Diagnostic test | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
| Fludeoxyglucose F-18Also: 18-FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18Given IV | Drug | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
| Fluorine F 18 L-glutamate Derivative BAY94-9392Also: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392Given IV | Drug | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
| Positron Emission Tomography (PET/CT)Also: Positron Emission Tomography/computer tomography, CT Scan, PET Scan, Positron Emission TomographyUndergo PET/CT | Diagnostic test | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
Primary outcome
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules
Time frame: 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 the estimates.
1 secondary outcome
Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC)
Time frame: Through study completion, an average of 2 years and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Mari Aparici principal investigator
Stanford Cancer Institute Palo Alto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computed Tomography, Fludeoxyglucose F-18 and Fluorine F 18 L-glutamate Derivative BAY94-9392 in people with Cigarette Smoker and Current Smoker, run by Andrei Iagaru at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules (time frame: Through study completion, an average of 2 years and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.