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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00038038
• Other study ID #: ID93-028
• Status: Withdrawn
• Phase: N/A
• First received: May 24, 2002
• Last updated: July 31, 2012
• Start date: January 1994
• Est. completion date: June 2003

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Metastases, Neoplasm
• Neoplasm Metastasis
• Neoplasms
• Squamous Cell Carcinoma

Intervention

Drug:
• 18F-fluoromisonidazole
Small amount of radioactive traces drug given by intravenous injection prior to PET Scan

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

Locations

Country	Name	City	State
United States	University of Texas M. D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No

External Links

•   UT MD Anderson Cancer Center website