A Phase 2 interventional study of Computed Tomography and Computed Tomography in Lung Carcinoma, Solitary Pulmonary Nodule and Cigarette Smoking Behavior, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 2 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Diagnostic
This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET)/computed tomography (CT) to the standard of care fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common building blocks of protein) called 18F-FSPG which may be able to recognize differences between tumor and healthy tissue. Since tumor cells are growing, they need to make protein, and other building blocks, for cell growth that are made from glutamate and other molecules. PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.
PRIMARY OBJECTIVES:
I. To compare the imaging characteristics of 18F-FSPG PET/CT with standard-of-care, 18F-FDG PET/CT.
II. To compare the imaging characteristics of 18F-FSPG PET/CT to standard-of-care 18F-FDG PET/CT in patients with newly diagnosed lung cancer.
III. To determine whether 18F-FSPG uptake in lung cancer can be predicted based on correlation with CD44 and amino acid transport system xc- (xC-) expression in surgical pathology specimens.
OUTLINE:
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
After completion of study, patients are followed up for 2 years if needed for diagnosis.
188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.
This study's enrollment of 46 is below the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.
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Exclusion Criteria:
For patients who do not have a tissue diagnosis:
Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Procedure: Computed Tomography · Radiation: fluorodeoxyglucose F-18 · Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392 · Other: Laboratory Biomarker Analysis · Procedure: Positron Emission Tomography · Procedure: Positron Emission Tomography (PET)
Undergo 18F-FDG PET/CT - standard of care
Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Undergo 18F-FSPG PET/CT
Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Undergo 18F-FDG PET/CT - standard of care
Also known as: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
Undergo 18F-FSPG PET/CT
Also known as: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392
Correlative studies
Undergo 18F-FDG PET/CT - standard of care
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging
Undergo 18F-FSPG PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging
Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
Sensitivity, specificity, overall accuracy and receiver operating characteristic (ROC) curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among analyzed patients. Area under the curve(AUC) is the area under the ROC curve, which is the plot of sensitivity by 1-specificity.
Time frame: Up to 2 years
CD44 and xC- Expression Levels in Tissue Samples(0-3)
The level of expression of xCT and CD44 proteins in the cytoplasmic membrane of tumor cells were examined by an experienced pathologist who was blinded to any patient and imaging information. The percentage of tumor cells positive for the marker and the intensity of staining were evaluated, the latter using a scale of 0 (none), 1+ (weak), 2+ (intermediate), and 3+ (strong) with a sample being reported as positive if greater than 10% of the tumor cells in the sample were positively stained with any intensity.
Time frame: Up to 2 years
Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor)
Maximum standardized uptake values (SUVmax) were normalized to lean body mass and measured with a 1 cm diameter round region of interest over the area of greatest uptake in the lesion being measured.
Time frame: Up to 2 years
Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
Sensitivity, specificity, overall accuracy and ROC curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of the biodistribution characteristics of 18F-FDG and 18F-FSPG tests. Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among all patients. Area under the curve(AUC) is the area under the ROC curve.
Time frame: Up to 2 years
Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the
Descriptive statistics, including means, standard deviations, and ranges for continuous
Time frame: Up to 2 years
This study enrolled 46 patients between two clinical sites (15 at Veterans Affairs-Tennessee Valley Health System Nashville, TN and 31 at Vanderbilt University Medical Center, Nashville, TN). The enrollment period was 6/16/15 to 1/5/21.
| Milestone | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| Started | 46 |
| Completed | 26 |
| Not completed | 20 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Did not get fspg scan | 18 |
| Withdrew: Treated between the fdg and fspg scan | 1 |
Sensitivity, specificity, overall accuracy and receiver operating characteristic (ROC) curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among analyzed patients. Area under the curve(AUC) is the area under the ROC curve, which is the plot of sensitivity by 1-specificity.
| proportion, range 0 to 1, higher better | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| FDG sensitivity(low and high) | 0.706 (0.489 to 0.922) |
| FDG specificity | 0.778 (0.506 to 1.000) |
| FDG accuracy | 0.731 (0.560 to 0.901) |
| FDG AUC(area under curve) | 0.817 (0.653 to 0.981) |
| ESPG sensitivity(low and high) | 0.824 (0.642 to 1.000) |
| ESPG specificity(low and high) | 0.667 (0.359 to 0.975) |
| ESPG accuracy | 0.769 (0.607 to 0.931) |
| ESPG AUC | 0.843 (0.682 to 1.000) |
The level of expression of xCT and CD44 proteins in the cytoplasmic membrane of tumor cells were examined by an experienced pathologist who was blinded to any patient and imaging information. The percentage of tumor cells positive for the marker and the intensity of staining were evaluated, the latter using a scale of 0 (none), 1+ (weak), 2+ (intermediate), and 3+ (strong) with a sample being reported as positive if greater than 10% of the tumor cells in the sample were positively stained with any intensity.
| IHC score, range 0 and above | Some Cancer Patients |
|---|---|
| CD44 | 2.6 ± 0.5 |
| xCT | 1 ± 1 |
Maximum standardized uptake values (SUVmax) were normalized to lean body mass and measured with a 1 cm diameter round region of interest over the area of greatest uptake in the lesion being measured.
| Maximum standardized uptake values (SUVm | Benign Patients | Cancer Patients |
|---|---|---|
| Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor) | 0.8 ± 0.7 | 3.9 ± 3.6 |
Sensitivity, specificity, overall accuracy and ROC curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of the biodistribution characteristics of 18F-FDG and 18F-FSPG tests. Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among all patients. Area under the curve(AUC) is the area under the ROC curve.
| proportion, range 0-1, higher better | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| FDG sensitivity | 0.8 (0.552 to 1) |
| FDG specificity | 0.857 (0.598 to 1) |
| FDG accuracy | 0.824 (0.642 to 1) |
| FDG AUC | 0.871 (0.7 to 1) |
| FSPG sensitivity | 0.2 (0 to 0.448) |
| FSPG specificity | 0.286 (0 to 0.62) |
| FSPG accuracy | 0.235 (0.034 to 0.437) |
| FSPG AUC | 0.8 (0.594 to 1) |
Descriptive statistics, including means, standard deviations, and ranges for continuous
Results for this outcome have not been posted.
Collected over From study entry to approximately 60 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) | 6/46 (13%) | 1/46 (2.2%) | 7/46 (15.2%) |
| Event | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/46 |
| Event | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| Non-cardiac chest painGeneral disorders | 4/46 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 4/46 |
| Age, Categorical(Participants) | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 23 |
| Sex: Female, Male(Participants) | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| Female | 16 |
| Male | 30 |
| Ethnicity (NIH/OMB)(Participants) | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 43 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 40 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) |
|---|---|
| United States | 46 |
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