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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-00177 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| LUN0106 | Other Identifier | Stanford Cancer Institute Palo Alto | |
| IRB-46607 | Other Identifier | Stanford IRB |
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| Name | Class |
|---|---|
| Canary Foundation | OTHER |
| Boston University | OTHER |
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Diagnostic Test | Undergo PET/CT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 2 years and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carina Mari Aparici | Stanford Cancer Institute Palo Alto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) | Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2023 |
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| Fludeoxyglucose F-18 | Drug | Given IV |
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| Fluorine F 18 L-glutamate Derivative BAY94-9392 | Drug | Given IV |
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| Positron Emission Tomography (PET/CT) | Diagnostic Test | Undergo PET/CT |
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| Through study completion, an average of 2 years and 6 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) | Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One lesion per participant was evaluated; therefore, lesion and participant counts match 1:1. | Posted | Number | 95% Confidence Interval | percentage | Through study completion, an average of 2 years and 6 months | Nodules | Nodules |
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| Secondary | 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. | Posted | Mean | Standard Error | probability | Through study completion, an average of 2 years and 6 months | Nodules | Nodules |
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Within 24 to 72hours after the 18F-FSPG PET/CT
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) | Patients received 18F-FSPG IV and, underwent a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients received 18F-FDG IV and underwent a second PET/CT scan over 30-60 minutes. Computed Tomography: Undergo PET/CT Fludeoxyglucose F-18: Given IV Fluorine F 18 L-glutamate Derivative BAY94-9392: Given IV Positron Emission Tomography: Undergo PET/CT | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carina Mari Aparici | Stanford University | 650-497 9280 | drmari@stanford.edu |
| Oct 24, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2023 | Oct 18, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D014054 | Tomography |
| D019788 | Fluorodeoxyglucose F18 |
| C000623325 | 4-(3-fluoropropyl)glutamic acid |
| D049268 | Positron-Emission Tomography |
| D000072078 | Positron Emission Tomography Computed Tomography |
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D014055 | Tomography, Emission-Computed |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
| D064847 | Multimodal Imaging |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Positive Predictive Value (PPV) |
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| Negative Predictive Value (NPV) |
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| Accuracy |
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