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

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Vanderbilt University Medical Center

Status and phase

Completed
Phase 2

Conditions

Solitary Pulmonary Nodule
Cigarette Smoking Behavior
Lung Carcinoma

Treatments

Procedure: Computed Tomography
Radiation: fluorodeoxyglucose F-18
Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
Procedure: Positron Emission Tomography
Procedure: Positron Emission Tomography (PET)
Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02448225
VICC THO 1524
P30CA068485 (U.S. NIH Grant/Contract)
NCI-2015-00748 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
Experimental group
Description:
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.
Treatment:
Other: Laboratory Biomarker Analysis
Procedure: Positron Emission Tomography (PET)
Procedure: Positron Emission Tomography
Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
Radiation: fluorodeoxyglucose F-18
Procedure: Computed Tomography

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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