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

This study has been completed.
Sponsor:
Collaborator:
NIHON MEDI-PHYSICS CO.,LTD.
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01502670
First received: December 21, 2011
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Lung Cancer
Drug: 18F-FACBC Radiotracer
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Correlation of Radiotracer Uptake with Histology [ Time Frame: Typically 1-2 months ] [ Designated as safety issue: No ]
    We will correlate radiotracer uptake with histology results


Enrollment: 10
Study Start Date: May 2009
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung Nodule Drug: 18F-FACBC Radiotracer
Test radiotracer uptake in lung nodule
Other Name: Radiotracer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502670

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
NIHON MEDI-PHYSICS CO.,LTD.
  More Information

Publications:
Responsible Party: David M. Schuster, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01502670     History of Changes
Other Study ID Numbers: IRB00006621, 14701
Study First Received: December 21, 2011
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Pulmonary nodules

ClinicalTrials.gov processed this record on October 29, 2014