Fluorine F 18 EF5 Positron Emission Tomography in Assessing Hypoxia in Patients With Newly Diagnosed Stage I, Stage II, Stage III, or Stage IV Head or Neck Squamous Cell Cancer of the Oral Cavity, Oropharynx, and Larynx

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Rationale: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment.

Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in assessing hypoxia in patients with newly diagnosed stage I, stage II, stage III, or stage IV squamous cell cancer of the oral cavity, oropharynx, and larynx.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Fluorides

Criteria

Inclusion Criteria:

• Patients must have a histologically confirmed and/or clinical and imaging evidence of a Stage 1-4 de novo mass in the larynx, pharynx or oral cavity

• Treatment plan should include Surgery (Biopsy or Excision) and may be followed by radiation and/ or concurrent chemotherapy

• Patients' disease must not require emergency surgical attention

• The need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation

• Patients must have a Karnofsky performance status >= 70

• Patients must have a clinical condition and physiologic status for which the standard initial therapy is surgical biopsy or resection

• Patients must have normal organ and marrow function as defined below:

• WBC > 2,000/mm^3

• Platelets > 100,000/mm^3

• Total bilirubin

• Creatinine

• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month)

• Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Serum pregnancy testing will be required for women of childbearing age

• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5

• Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant women and women who are breastfeeding

• Patients whose clinical status requires that surgery for their HNSCC be performed emergently or in a time course that does not allow scheduling of an 18F-EF5 PET scan preceding surgery and chemoradiation