Lung Cancer Clinical Trial

18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules

Summary

This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.

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Full Description

PRIMARY OBJECTIVES:

I. Comparison of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) accumulation with fludeoxyglucose F-18 (18F-FDG) accumulation to assess whether (4S)-4-(3-18F-Fluoropropyl)-L-Glutamate (18F-FSPG)-PET is better at discriminating between benign and malignant nodules.

SECONDARY OBJECTIVES:

I. To develop and validate early lung cancer detection biomarkers that would directly impact the growing need to integrate imaging and non-invasive molecular diagnostics for indeterminate pulmonary nodules and allow physicians to avoid unnecessary invasive procedures in patients with benign lung disease.

OUTLINE:

Patients receive 18F-FSPG intravenously (IV) and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG and undergo a second PET/CT scan over 30-60 minutes.

After completion of study, patients are followed up within 24-72 hours.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be eligible if the dominant nodule is 7 to 30 mm
Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule)
Current or former cigarette smoker, with >= 20 pack years
Documented informed consent

Exclusion Criteria:

History or previous diagnosis of lung cancer
Cancer diagnosis within the last 5 years
Pregnant or nursing

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT03824535

Recruitment Status:

Recruiting

Sponsor:

Andrei Iagaru

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There is 1 Location for this study

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Stanford Cancer Institute Palo Alto
Palo Alto California, 94304, United States More Info
Mahima Goel
Contact
650-723-0371
[email protected]
Carina M Aparici, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT03824535

Recruitment Status:

Recruiting

Sponsor:


Andrei Iagaru

How clear is this clinincal trial information?

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