Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole

• Status: Withdrawn
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Misonidazole

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