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

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ClinicalTrials.gov Identifier: NCT01502670
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: 18F-FACBC Radiotracer Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of the Utility of the Novel Amino Acid Radiotracer Anti-[18 F]FACBC for the Noninvasive Imaging of Lung Nodules
Study Start Date : May 2009
Primary Completion Date : June 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lung Nodule Drug: 18F-FACBC Radiotracer
Test radiotracer uptake in lung nodule
Other Name: Radiotracer

Outcome Measures

Primary Outcome Measures :
  1. Correlation of Radiotracer Uptake with Histology [ Time Frame: Typically 1-2 months ]
    We will correlate radiotracer uptake with histology results

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502670

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
More Information

Responsible Party: David M. Schuster, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01502670     History of Changes
Other Study ID Numbers: IRB00006621
14701 ( Other Identifier: Other )
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by David M. Schuster, MD, Emory University:
Pulmonary nodules