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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038038 |
Purpose
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent: 1.) Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)? 2.) If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors? And 3.) Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors? 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-fluromisonidazole (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.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Cell Carcinoma Head and Neck Neoplasms Metastases, Neoplasm |
Drug: 18F-fluoromisonidazole |
Phase I |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label |
| Official Title: | Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
More Information
| Study ID Numbers: | ID93-028 |
| Study First Received: | May 24, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00038038 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Squamous cell carcinoma of head and neck |
|
Radiation-Sensitizing Agents Ro 07-0741 Head and Neck Neoplasms Epidermoid Carcinoma Neoplasm Metastasis |
Neoplasms, Squamous Cell Squamous Cell Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
|
Neoplasms by Histologic Type Ro 07-0741 Physiological Effects of Drugs Pharmacologic Actions Carcinoma Neoplasms Neoplastic Processes Neoplasms by Site |
Pathologic Processes Radiation-Sensitizing Agents Head and Neck Neoplasms Neoplasm Metastasis Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |