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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This study has been withdrawn prior to enrollment.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

May 24, 2002
July 31, 2012
January 1994
June 2003   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00038038 on ClinicalTrials.gov Archive Site
Not Provided
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Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole

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?

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Squamous Cell Carcinoma
  • Head and Neck Neoplasms
  • Metastases, Neoplasm
  • 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
Experimental: PET + 18F-fluoromisonidazole
Interventions:
  • Drug: 18F-fluoromisonidazole
  • Procedure: PET scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2003
June 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038038
ID93-028
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Study Chair: Donald A Podoloff, M.D. UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP