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

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: NCT01020097
Recruitment Status : Unknown
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2009
Last Update Posted : December 15, 2015
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Drug: fluorine F18 EF5 Procedure: immunohistochemistry staining method Procedure: biopsy Procedure: Positron Emission tomography Not Applicable

Detailed Description:

Detailed DescriptionPRIMARY OBJECTIVES:

I. Describe the patterns and levels of 18F-EF5 in Stage 1 - 4 de novo HNSCC of the oral cavity, oropharynx and larynx.

II. Determine whether the 18F-EF5 PET images are predictive of patient outcome (event-free survival; EFS and overall survival; OS).

III. Determine whether any statistically significant prognostic relationships found in the corresponding grant are independent of nodal status.


I. Explore the relationship between 18F-EF5 signal and other measures of hypoxia (serum OPN; HIF1alpha protein expression), proliferation (Ki67+ cells/high power field (HPF)), apoptosis and radiation resistance (pAkt expression).


Patients undergo fluorine F 18-EF5 positron emission tomography imaging. Scans are performed 180 minutes following injection.

After completion of study, patients are followed at 2-4 weeks and 4-6 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
Study Start Date : March 2009
Actual Primary Completion Date : December 2013

Arm Intervention/treatment
Arm I
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
Drug: fluorine F18 EF5
Given IV
Other Name: 18F-EF5
Procedure: immunohistochemistry staining method
Correlative study
Other Name: immunohistochemistry
Procedure: biopsy
Correlative study
Other Name: biopsies
Procedure: Positron Emission tomography
Undergo scan
Other Name: FDG-PET, PET, PET scan, tomography, emission computed

Primary Outcome Measures :
  1. 18F-EF5 standardized uptake values (SUV)
  2. Tumor to normal tissue (T:N) ratios

Secondary Outcome Measures :
  1. Event-free survival and overall survival

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

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

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): NCT01020097

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01020097     History of Changes
Other Study ID Numbers: UPCC 17308
First Posted: November 24, 2009    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Stage 1 squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs