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FACBC for Head and Neck Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Change in Principal Investigator and protocol revisions delayed study start and ultimately the decision was made to cancel the study.)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
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FACBC Drug: FACBC

Primary Outcome Measures :
  1. 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. .

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Age 18 years or older.
  2. Biopsy proven, untreated squamous cell carcinoma of the oral cavity.
  3. Clinical, laboratory, or diagnostic imaging findings on CT, MRI, or 18F-FDG PET/CT.
  4. Ability to lie still for PET scanning.
  5. Able to provide written informed consent.

Exclusion Criteria:

  1. Age less than 18 years.
  2. Prior history of carcinoma.
  3. Not a candidate for surgical resection based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
  4. Inability to lie still for PET scanning.
  5. Inability to provide written informed consent.

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 identifier (NCT number): NCT01933269

Sponsors and Collaborators
Emory University
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Principal Investigator: Ayse Karagulle Kendi, MD Emory University
Study Director: David Schuster, MD Emory University

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Responsible Party: David M. Schuster, MD, Principal Investigator, Emory University Identifier: NCT01933269    
Other Study ID Numbers: IRB00062214
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site