Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Squamous Cell Carcinoma Head and Neck Neoplasms Metastases, Neoplasm |
Drug: 18F-fluoromisonidazole Procedure: PET scan |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole |
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | January 1994 |
| Study Completion Date: | June 2003 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PET + 18F-fluoromisonidazole |
Drug: 18F-fluoromisonidazole
Small amount of radioactive traces drug given by intravenous injection prior to PET Scan
Other Name: 18F-FMISO
Procedure: PET scan
Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| University of Texas M. D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Donald A Podoloff, M.D. | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038038 History of Changes |
| Other Study ID Numbers: | ID93-028 |
| Study First Received: | May 24, 2002 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Squamous cell carcinoma of head and neck |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasm Metastasis Anoxia Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell |
Neoplasms by Site Neoplastic Processes Pathologic Processes Signs and Symptoms, Respiratory Signs and Symptoms Fluoromisonidazole Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013