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


N/A
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma, Head and Neck Neoplasms, Metastases, Neoplasm

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Direct Oxygen Measurements

Outcome 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.

Safety Issue:

No

Principal Investigator

Donald A Podoloff, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID93-028

NCT ID:

NCT00038038

Start Date:

January 1994

Completion Date:

June 2003

Related Keywords:

  • Squamous Cell Carcinoma
  • Head and Neck Neoplasms
  • Metastases, Neoplasm
  • Squamous cell carcinoma of head and neck
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Anoxia

Name

Location

University of Texas M. D. Anderson Cancer CenterHouston, Texas  77030