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

NCT02448225 | Completed Phase 2 Results DMC

• 3 other identifiers: VICC THO 1524NCI-2015-00748P30CA068485
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Carcinoma; Solitary Pulmonary Nodule; Cigarette Smoking Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

Other Outcomes (1)

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

  Up to 2 years

Study Arms (1)

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

EXPERIMENTAL

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)

Interventions

Computed Tomography PROCEDURE

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

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

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

fluorodeoxyglucose F-18 RADIATION

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

Also known as: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose

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

Fluorine F 18 L-glutamate Derivative BAY94-9392 DRUG

Undergo 18F-FSPG PET/CT

Also known as: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392

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

Laboratory Biomarker Analysis OTHER

Correlative studies

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

Positron Emission Tomography PROCEDURE

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

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

Positron Emission Tomography (PET) PROCEDURE

Undergo 18F-FSPG PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Tennessee Valley Health System Nashville

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Lung Neoplasms; Solitary Pulmonary Nodule; Cigarette Smoking

Interventions

Fluorodeoxyglucose F18; 4-(3-fluoropropyl)glutamic acid; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Teresa Melton
• Organization: Vanderbilt-Ingram Cancer Center

teresa.melton@vumc.org

615-936-7423

Study Officials

• Chirayu Shah, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Radiology

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 19, 2015
• Study Start: June 16, 2015
• Primary Completion: August 2, 2021
• Study Completion: October 10, 2022
• Last Updated: October 19, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-10

Locations

US (2)