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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-16

Study Completion Date

2022-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Carcinoma Solitary Pulmonary Nodule Cigarette Smoking Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

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

Computed Tomography

Intervention Type PROCEDURE

Undergo 18F-FSPG PET/CT

fluorodeoxyglucose F-18

Intervention Type RADIATION

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

Fluorine F 18 L-glutamate Derivative BAY94-9392

Intervention Type DRUG

Undergo 18F-FSPG PET/CT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Positron Emission Tomography

Intervention Type PROCEDURE

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

Positron Emission Tomography (PET)

Intervention Type PROCEDURE

Undergo 18F-FSPG PET/CT

Interventions

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Computed Tomography

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

Intervention Type PROCEDURE

Computed Tomography

Undergo 18F-FSPG PET/CT

Intervention Type PROCEDURE

fluorodeoxyglucose F-18

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

Intervention Type RADIATION

Fluorine F 18 L-glutamate Derivative BAY94-9392

Undergo 18F-FSPG PET/CT

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Positron Emission Tomography

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

Intervention Type PROCEDURE

Positron Emission Tomography (PET)

Undergo 18F-FSPG PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography 18FDG FDG Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid 18F-FSPG BAY94-9392 Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Scan proton magnetic resonance spectroscopic imaging Medical Imaging, Positron Emission Tomography Positron Emission Tomography Scan proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No