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

Lung Cancer Clinical Trial

— SPN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502670
• Other study ID #: IRB00006621
• Secondary ID: 14701
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2011
• Last updated: November 18, 2013
• Start date: May 2009
• Est. completion date: January 2013

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• 18F-FACBC Radiotracer
Test radiotracer uptake in lung nodule

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	NIHON MEDI-PHYSICS CO.,LTD.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Amzat R, Taleghani P, Miller DL, Beitler JJ, Bellamy LM, Nye JA, Yu W, Savir-Baruch B, Osunkoya AO, Chen Z, Auffermann WF, Goodman MM, Schuster DM. Pilot study of the utility of the synthetic PET amino-acid radiotracer anti-1-amino-3-[(18)F]fluorocyclobut — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Radiotracer Uptake with Histology	We will correlate radiotracer uptake with histology results	Typically 1-2 months	No