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

NCT ID: NCT00038038

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1994-01-31

Study Completion Date

2003-06-30

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Squamous Cell Carcinoma Head and Neck Neoplasms Metastases, Neoplasm

Keywords

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Squamous cell carcinoma of head and neck

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET + 18F-fluoromisonidazole

Group Type EXPERIMENTAL

18F-fluoromisonidazole

Intervention Type DRUG

Small amount of radioactive traces drug given by intravenous injection prior to PET Scan

PET scan

Intervention Type PROCEDURE

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

Interventions

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18F-fluoromisonidazole

Small amount of radioactive traces drug given by intravenous injection prior to PET Scan

Intervention Type DRUG

PET scan

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

Intervention Type PROCEDURE

Other Intervention Names

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18F-FMISO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald A Podoloff, M.D.

Role: STUDY_CHAIR

UT MD Anderson Cancer Center

Locations

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University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

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ID93-028

Identifier Type: -

Identifier Source: org_study_id