A Pilot Study of the Utility of the Novel Amino Acid Radiotracer Anti-[18 F]FACBC for the Noninvasive Imaging of Lung Nodules
18 Years
N/A
Both
Lung Cancer
Trial Information
A Pilot Study of the Utility of the Novel Amino Acid Radiotracer Anti-[18 F]FACBC for the Noninvasive Imaging of Lung Nodules
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Correlation of Radiotracer Uptake with Histology
Outcome Description:
We will correlate radiotracer uptake with histology results
Outcome Time Frame:
Typically 1-2 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
14701
NCT ID:
NCT01502670
Start Date:
May 2009
Completion Date:
January 2013
Related Keywords:
- Lung Cancer
- Pulmonary nodules
- Lung Neoplasms
Name | Location |
|---|---|
| Emory University | Atlanta, Georgia 30322 |
