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
NCT ID: NCT01020097
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2009-03-31
2013-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm I
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
fluorine F18 EF5
Given IV
immunohistochemistry staining method
Correlative study
biopsy
Correlative study
Positron Emission tomography
Undergo scan
Interventions
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fluorine F18 EF5
Given IV
immunohistochemistry staining method
Correlative study
biopsy
Correlative study
Positron Emission tomography
Undergo scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 17308
Identifier Type: -
Identifier Source: org_study_id
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