Clinical trial NCT03824535: 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
Official title: 18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoker
Current Smoker
Former Smoker
Multiple Pulmonary Nodules
Pulmonary Nodule
Keywords: Indeterminate lung nodule
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Canary Foundation
name: Boston University
name: United States Department of Defense
First posted: 2019-01-31
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 indeterminate 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.

Detailed 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.

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

Primary outcomes:
measure: Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules
timeFrame: Through study completion, an average of 2 years and 6 months
Secondary outcomes:
measure: Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC)
timeFrame: Through study completion, an average of 2 years and 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute Palo Alto
state: California
Study officials:
affiliation: Stanford Cancer Institute Palo Alto
name: Carina Mari Aparici
role: PRINCIPAL_INVESTIGATOR
References: