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

NCT01020097 | Completed DMC

• 1 other identifier: UPCC 17308
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma

Keywords

Stage 1 squamous cell carcinoma of the larynx

Outcome Measures

Primary Outcomes (2)

• 18F-EF5 standardized uptake values (SUV)

  Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.

  Study completion

• Tumor to normal tissue (T:N) ratios

  Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.

  Study completion

Secondary Outcomes (1)

• Event-free survival and overall survival

  5 years

Study Arms (1)

Arm I

OTHER

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

Drug: fluorine F18 EF5; Procedure: immunohistochemistry staining method; Procedure: biopsy; Procedure: Positron Emission tomography

Interventions

fluorine F18 EF5 DRUG

Given IV

Also known as: 18F-EF5

Arm I

immunohistochemistry staining method PROCEDURE

Correlative study

Also known as: immunohistochemistry

Arm I

biopsy PROCEDURE

Correlative study

Also known as: biopsies

Arm I

Positron Emission tomography PROCEDURE

Undergo scan

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

Immunohistochemistry; Biopsy; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 24, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)