FACBC for Head and Neck Cancers
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|ClinicalTrials.gov Identifier: NCT01933269|
Recruitment Status : Withdrawn (Change in Principal Investigator and protocol revisions delayed study start and ultimately the decision was made to cancel the study.)
First Posted : September 2, 2013
Last Update Posted : February 5, 2018
The purpose of this study is to assess a relatively new PET (Positron emission tomography) radiotracer called FACBC in the assessment of head and neck cancer. FDG (Flourine Deoxyglucose) is currently used for PET imaging, but has limitations in head and neck cancer. These limitations include problems with specificity, high background uptake from normal structures, difficulty delineating intracranial invasion, and the need to wait several weeks after chemotherapy and radiation before imaging. As an amino acid radiotracer, rather than a glucose radiotracer, FACBC overcomes some of these limitations. FACBC does not yet have FDA (Food and Drug Administration) approval, but does show promise in initial work in patients with prostate cancer and brain tumors. Dosimetry work on FACBC has been performed at Emory.
Our study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical resection (ie, surgery without preceding chemotherapy or radiation). Patients must have pre-surgical imaging, either with a contrast enhanced CT, FDG PET, or MRI. Patients who consent to participate will receive one FACBC PET/CT of the neck, which will require a low dose "transmission" CT of the neck, an intravenous injection of the radiotracer, and imaging of the neck that will last up to 1 hour. Patients will have to lie still during the imaging time. Total participation time including set up should be less than 90 minutes. Imaging results will be analyzed and compared with conventional imaging as well as the surgical pathology results
|Condition or disease||Intervention/treatment||Phase|
|Cancers of the Head and Neck||Drug: FACBC||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Initial Evaluation of Anti-1-amino-F-18 Flurocyclobutane-1carboxylic Acid (Anti-18F-FACBC) in the Assessment of Head and Neck Cancer: A Pilot Study.|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||February 1, 2018|
- The presence of FACBC radiotracer uptake in Head and neck tumors on PET scans [ Time Frame: 1 day ]The results of the FACBC PET scan will be validated by direct comparison with the pathology findings obtained at surgery. .
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): NCT01933269
|Principal Investigator:||Ayse Karagulle Kendi, MD||Emory University|
|Study Director:||David Schuster, MD||Emory University|