Cigarette Smoker, Current Smoker, Former Smoker, Multiple Pulmonary Nodules, Pulmonary Nodule
Conditions
Keywords
Indeterminate lung nodule
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTComputed Tomography
Undergo PET/CT
DRUGFludeoxyglucose F-18
Given IV
Given IV
DIAGNOSTIC_TESTPositron Emission Tomography (PET/CT)
Undergo PET/CT
Sponsors
Canary Foundation
Boston University
United States Department of Defense
Andrei Iagaru
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC) | Through study completion, an average of 2 years and 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: Through study completion, an average of 2 years and 6 months
Population: One lesion per participant was evaluated; therefore, lesion and participant counts match 1:1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (18F-FSPG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Specificity | 100 percentage |
| Diagnostic (18F-FSPG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Negative Predictive Value (NPV) | 100 percentage |
| Diagnostic (18F-FSPG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Positive Predictive Value (PPV) | 100 percentage |
| Diagnostic (18F-FSPG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Accuracy | 100 percentage |
| Diagnostic (18F-FSPG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Sensitivity | 100 percentage |
| Diagnostic (18F-FDG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Accuracy | 79 percentage |
| Diagnostic (18F-FDG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Sensitivity | 70 percentage |
| Diagnostic (18F-FDG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Specificity | 100 percentage |
| Diagnostic (18F-FDG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Positive Predictive Value (PPV) | 100 percentage |
| Diagnostic (18F-FDG PET/CT) | Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules | Negative Predictive Value (NPV) | 57 percentage |
Comparison: Analysis applies to the row 'Specificity' in the Outcome Measure data table.p-value: 0.02Wilcoxon (Mann-Whitney)
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.
Time frame: Through study completion, an average of 2 years and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (18F-FSPG PET/CT) | Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC) | 0.84 probability | Standard Error 0.1 |
| Diagnostic (18F-FDG PET/CT) | Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC) | 1.0 probability | Standard Error 0 |
p-value: 0.004Wilcoxon (Mann-Whitney)
p-value: 0.05Wilcoxon (Mann-Whitney)
p-value: 0.06Wilcoxon (Mann-Whitney)