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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

Primary Purpose

Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluorine F18 EF5
immunohistochemistry staining method
biopsy
Positron Emission tomography
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Squamous Cell Carcinoma focused on measuring Stage 1 squamous cell carcinoma of the larynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm I

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Event-free survival and overall survival
Length of time from end of treatment to recurrence or death

Full Information

First Posted
November 18, 2009
Last Updated
April 23, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01020097
Brief Title
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
Official Title
Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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. SECONDARY OBJECTIVES: 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). OUTLINE: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
Stage 1 squamous cell carcinoma of the larynx

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Other
Arm Description
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
Intervention Type
Drug
Intervention Name(s)
fluorine F18 EF5
Other Intervention Name(s)
18F-EF5
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
immunohistochemistry staining method
Other Intervention Name(s)
immunohistochemistry
Intervention Description
Correlative study
Intervention Type
Procedure
Intervention Name(s)
biopsy
Other Intervention Name(s)
biopsies
Intervention Description
Correlative study
Intervention Type
Procedure
Intervention Name(s)
Positron Emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo scan
Primary Outcome Measure Information:
Title
18F-EF5 standardized uptake values (SUV)
Description
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.
Time Frame
Study completion
Title
Tumor to normal tissue (T:N) ratios
Description
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.
Time Frame
Study completion
Secondary Outcome Measure Information:
Title
Event-free survival and overall survival
Description
Length of time from end of treatment to recurrence or death
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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