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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038038
Recruitment Status : Withdrawn (No participants enrolled, study terminated.)
First Posted : May 27, 2002
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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?

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Head and Neck Neoplasms Metastases, Neoplasm Drug: 18F-fluoromisonidazole Procedure: PET scan Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 1994
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

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 Name: 18F-FMISO

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

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038038

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038038     History of Changes
Other Study ID Numbers: ID93-028
First Posted: May 27, 2002    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Signs and Symptoms, Respiratory
Signs and Symptoms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents