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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00038038

Collaborator

(none)

Enrollment

Location

Arm

113

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma Head and Neck Neoplasms Metastases, Neoplasm	Drug: 18F-fluoromisonidazole Procedure: PET scan	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 1994

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET + 18F-fluoromisonidazole	Drug: 18F-fluoromisonidazole Small amount of radioactive traces drug given by intravenous injection prior to PET Scan Other Names: 18F-FMISO Procedure: PET scan Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection

Arm

Intervention/Treatment

Experimental: PET + 18F-fluoromisonidazole

Drug: 18F-fluoromisonidazole

Small amount of radioactive traces drug given by intravenous injection prior to PET Scan

Other Names:

18F-FMISO

Procedure: PET scan

Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection

Outcome Measures

Primary Outcome Measures

Direct Oxygen Measurements [PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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