Amino Acid Tracer (FACBC) Positron Emission Tomography for Lung Nodule

Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Drug: 18F-FACBC Radiotracer

• Registration Number: NCT01502670
• Lead Sponsor: Emory University

Brief Summary

This study will look at how the \[18\]FACBC goes into the lung nodules. This will hopefully lead to the development of better imaging techniques to look at lung nodules. \[18\]FACBC is not approved by the FDA (Food and Drug Administration). This study will help to determine if it should be approved by the FDA.

Detailed Description

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to tumor cells, as has been shown in the detection and staging of prostate cancer and for brain tumors. In this study we are going to test this new substance in patients with lung nodules. Lung nodules are a common finding. It is very important to non-invasively determine whether the nodule is cancer or not, as early cancer detection and treatment may cure the disease. The substance is called \[18\]FACBC and it is given in the form of an injection into a vein. After the substance reaches the lung nodules, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans but this substance often goes to inflammatory tissues as well. This new substance does not significantly go to inflammatory tissues, and may allow tumors in the lungs to be better identified.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-30
• Study First Posted: 2012-01-02
• Primary Completion: 2012-06
• Study Completion: 2013-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients must be 18 years of age or older.
2. Patients with a history of cancer who have a solitary pulmonary nodule between 1-3 cm in short axis with clinical and CT characteristics warranting surgical removal (see below).
3. Clinical, laboratory, or diagnostic imaging findings on CT or 18F-FDG PET-CT do not suggest the possibility of the SPN being part of a metastatic process.
4. Ability to lie still for PET scanning
5. Patients must be able to provide written informed consent.

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Exclusion Criteria

1. Age less than 18.
2. Active carcinoma with known metastatic disease.
3. Size of primary lesion less than 1 cm or greater than 3 cm
4. Not a candidate for surgical resection or biopsy based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
5. Inability to lie still for PET scanning
6. Cannot provide written informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung Nodule	18F-FACBC Radiotracer	-

Primary Outcome Measures

Name	Time	Method
Correlation of Radiotracer Uptake with Histology	Typically 1-2 months	We will correlate radiotracer uptake with histology results

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States