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

This study has been withdrawn prior to enrollment.
(No participants enrolled, study terminated.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038038
First received: May 24, 2002
Last updated: July 31, 2012
Last verified: July 2012
  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?
  3. Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?

Condition Intervention
Squamous Cell Carcinoma
Head and Neck Neoplasms
Metastases, Neoplasm
Drug: 18F-fluoromisonidazole
Procedure: PET scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Direct Oxygen Measurements [ Time Frame: PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 1994
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET + 18F-fluoromisonidazole Drug: 18F-fluoromisonidazole
Small amount of radioactive traces drug given by intravenous injection prior to PET Scan
Other Name: 18F-FMISO
Procedure: PET scan
Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038038

Locations
United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Donald A Podoloff, M.D. UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038038     History of Changes
Other Study ID Numbers: ID93-028
Study First Received: May 24, 2002
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Squamous cell carcinoma of head and neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Fluoromisonidazole
Misonidazole
Anti-Infective Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014