Clinical trial NCT00038038: Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
Official title: Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Squamous Cell Carcinoma
Head and Neck Neoplasms
Metastases, Neoplasm
Keywords: Squamous cell carcinoma of head and neck
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2002-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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?
3. Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?

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 criteria: 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

Primary outcomes:
measure: Direct Oxygen Measurements
timeFrame: PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Donald A Podoloff, M.D.
role: STUDY_CHAIR
References: