Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Lung Neoplasms

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Protective Agents

Radiopharmaceuticals

Antimetabolites

Antiviral Agents

Glutamic Acid

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.

Undergo 18F-FDG PET/CT - standard of care

Computed Tomography

fluorodeoxyglucose F-18

Fluorine F 18 L-glutamate Derivative BAY94-9392

Laboratory Biomarker Analysis

Positron Emission Tomography

Positron Emission Tomography (PET)

Chirayu Shah, MD

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.

18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

PET Imaging of Lung Cancer and Indeterminate Pulmonary Nodules With 18F-FSPG

Descriptive statistics, including means, standard deviations, and ranges for continuous

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.

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.

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.

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.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Associate Professor of Clinical Radiology

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.

Computed Tomography: Undergo 18F-FDG PET/CT - standard of care

Computed Tomography: Undergo 18F-FSPG PET/CT

fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care

Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT

Laboratory Biomarker Analysis: Correlative studies

Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care

Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT

Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Teresa Melton

FDG sensitivity(low and high)

FDG specificity

FDG accuracy

FDG AUC(area under curve)

ESPG sensitivity(low and high)

ESPG specificity(low and high)

ESPG accuracy

ESPG AUC

Patients analyzed among enrolled patients

Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules

CD44

Some Cancer Patients

CD44 and xC- Expression Levels in Tissue Samples(0-3)

Benign Patients

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.

Computed Tomography: Undergo 18F-FDG PET/CT - standard of care

Computed Tomography: Undergo 18F-FSPG PET/CT

fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care

Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT

Cancer Patients

enrolled patients included 7 benign and 19 cancer patients.

Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor)

FDG sensitivity

FDG AUC

FSPG sensitivity

FSPG specificity

FSPG accuracy

FSPG AUC

Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)

Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the

Overall Study

Patients undergo 18F-FDG PET/CT scan first. Within 7 working days, patients receive 4-\[18F\]Fluoroglutamine IV and 60 minutes after injection, undergo 4-\[18F\]Fluoroglutamine PET/CT before the start of therapy.

Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT

18F-(2S,4R)4-fluoroglutamine

Hui Wang, MD

This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules. \[18F\]Fluoroglutamine PET may provide additional information that help diagnose lung cancer.

4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

[18F] 4-L-Fluoroglutamine (2S,4R) PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

Sensitivity, specificity, diagnostic accuracy of 4-\[18F\]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test.

The evaluation of the Incidence of Treatment-Emergent Adverse Events starts from the day of F-Gln examination until 30 days later; Treatment-Emergent Adverse Events are evaluated according to version 4.03 CTC-AE criteria.

Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules	NCT02448225	Lung Carcinoma Solitary Pulmon... Cigarette Smoki...	Computed Tomogr... Computed Tomogr... fluorodeoxygluc... Fluorine F 18 L... Laboratory Biom... Positron Emissi... Positron Emissi...	40 Years - 80 Years	Vanderbilt-Ingram Cancer Center
18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules	NCT02448225	Lung Carcinoma Solitary Pulmon... Cigarette Smoki...	Computed Tomogr... Computed Tomogr... fluorodeoxygluc... Fluorine F 18 L... Laboratory Biom... Positron Emissi... Positron Emissi...	40 Years - 80 Years	Vanderbilt-Ingram Cancer Center
18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules	NCT02448225	Lung Carcinoma Solitary Pulmon... Cigarette Smoki...	Computed Tomogr... Computed Tomogr... fluorodeoxygluc... Fluorine F 18 L... Laboratory Biom... Positron Emissi... Positron Emissi...	40 Years - 80 Years	Vanderbilt-Ingram Cancer Center
4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules	NCT03568799	Lung Cancer Solitary Pulmon... Cigarette Smoki...	18F-(2S,4R)4-fl...	18 Years - 79 Years	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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