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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02448225
Other study ID # VICC THO 1524
Secondary ID NCI-2015-00748P3
Status Completed
Phase Phase 2
First received
Last updated
Start date June 16, 2015
Est. completion date October 10, 2022

Study information

Verified date October 2022
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 10, 2022
Est. primary completion date August 2, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - Have an indeterminate untreated pulmonary nodule (IPN) (7-30 mm diameter) on CT, or an indeterminate lung mass (> 30 mm diameter), without prior examinations that establish that the lesion has been stable for two or more years, untreated. or - Have a newly diagnosed, untreated primary lung cancer diameter 7 mm or more. - Be able to give informed consent, which will include a layman's explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPG - Must agree at the time of study entry to undergo clinically indicated biopsy(ies) or a 24-month period of follow-up, as needed, to resolve the etiology of their IPN(s) or lung mass(es). Exclusion Criteria: - Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-HCG pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans, in accordance with the standard policy of the Medical Imaging Service at our facility. Women who have experienced 24 consecutive months of amenorrhea, have reached at least 60 years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol - Patients with a body weight of 400 pounds or more or a body habitus or disability that will not permit the imaging protocol to be performed - A recognized active lung infection - Previous systemic or radiation treatment for cancer of any type within 1 year - For patients who do not have a tissue diagnosis: - Non-oncologic severe co-morbidities suggesting a life span of less than two years if not treated, as determined by the potential subject's treating physician.

Study Design


Intervention

Procedure:
Computed Tomography
Undergo 18F-FDG PET/CT - standard of care
Computed Tomography
Undergo 18F-FSPG PET/CT
Radiation:
fluorodeoxyglucose F-18
Undergo 18F-FDG PET/CT - standard of care
Drug:
Fluorine F 18 L-glutamate Derivative BAY94-9392
Undergo 18F-FSPG PET/CT
Other:
Laboratory Biomarker Analysis
Correlative studies
Procedure:
Positron Emission Tomography
Undergo 18F-FDG PET/CT - standard of care
Positron Emission Tomography (PET)
Undergo 18F-FSPG PET/CT

Locations

Country Name City State
United States Tennessee Valley Health System Nashville Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Descriptive statistics, including means, standard deviations, and ranges for continuous Up to 2 years
Primary 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.
Up to 2 years
Secondary 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. Up to 2 years
Secondary 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. Up to 2 years
Secondary 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.
Up to 2 years
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