Clinical trial NCT01933269: FACBC for Head and Neck Cancers
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Cancers of the Head and Neck
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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.

Primary outcomes:
measure: The presence of FACBC radiotracer uptake in Head and neck tumors on PET scans
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Ayse Karagulle Kendi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: David Schuster, MD
role: STUDY_DIRECTOR
References: