Trials / Completed
CompletedNCT01020097
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
Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluorine F18 EF5 | Given IV |
| PROCEDURE | immunohistochemistry staining method | Correlative study |
| PROCEDURE | biopsy | Correlative study |
| PROCEDURE | Positron Emission tomography | Undergo scan |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2009-11-24
- Last updated
- 2020-04-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01020097. Inclusion in this directory is not an endorsement.