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A Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients


Inclusion Criteria:



- Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx,
paranasal sinus, salivary, and thyroid malignancies)Any unknown primary squamous cell
carcinoma of head and neck with gross nodes is allowed (2002 AJCC)

- 18 years of age or older

- Must not have received prior radiation therapy or chemotherapy for this diagnosis.
Patients who have had their primary site tumor removed by surgery but still present
with grossly enlarged lymph nodes are eligible for this study.

- Karnofsky performance status ≥ 70.

Exclusion Criteria:

- all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies

- prior chemotherapy or radiotherapy within the last three years

- patients that underwent surgical resection for the same disease (except for biopsy or
surgery removing primary site tumor but still present with grossly enlarged lymph
nodes)

- any prior radiotherapy to the head and neck region

- pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To improve the accuracy of hypoxia imaging for head and neck cancers through pixel by pixel kinetic analysis of 18F-MISO tracer of dynamic PET images.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Nancy Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-070

NCT ID:

NCT00606294

Start Date:

June 2004

Completion Date:

June 2016

Related Keywords:

  • Head and Neck Cancer
  • Head
  • Neck
  • 04-070
  • Head and Neck Neoplasms
  • Anoxia

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021