Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent:
- Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?
- If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors?
- Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?
Study Overview
Status
Intervention / Treatment
Detailed Description
Hypoxic (low oxygen) cells have long been known to exist in animal tumors. It is also known that hypoxic cells are more difficult to eliminate with radiotherapy than tumor cells at normal levels of oxygen (normoxic cells). However, the extent to which hypoxic cells limit the curability of human tumors is uncertain. To determine if hypoxic cells exist in human tumors and how hypoxic cells might influence the efficacy of radiotherapy, this study involves direct measurements of oxygen levels in human tumors compared to the tumor uptake of the experimental drug, 18F-fluoromisonidazole (18F-FMISO), visualized with PET scanning. 18F-fluoromisonidazole has been used with PET imaging to tell the difference between growing tumors which have high and low oxygen content.
Before beginning radiotherapy, a PET scan (series of pictures, 20 min. scan) will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug, 18F-fluoromisonidazole (18F-FMISO) to observe the active hypoxia tumors areas. Upon completion of the 18F-FMISO PET scan, direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic (CT) guidance. The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy. The measurement obtained by 18F-FMISO PET scanning (non-invasive technique) and by direct needle measurements (invasive technique) will be correlated with the eventual treatment outcome for future use.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- University of Texas M. D. Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of head and neck wth metastatic neck nodes greater than or equal to 2cm
- Karnofsky performance status greater or equal to 60%
Exclusion Criteria:
- No prior irradiation or surgery to head/neck area
- No prior chemotherapy within 1 month of participation and have recovered from associated related effects
- Not pregnant
- Any intercurrent medical or physiologic disorder which would prevent informed consent
- Underlying medical problems which would compromise technical ability to deliver a "standard course" of radiation therapy
- Patients with PT or PTT over 1.5 times normal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: PET + 18F-fluoromisonidazole
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Small amount of radioactive traces drug given by intravenous injection prior to PET Scan
Other Names:
Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Direct Oxygen Measurements
Time Frame: PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.
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PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Donald A Podoloff, M.D., UT MD Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID93-028
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