Cervix Hypoxia FAZA

N/AActive Not RecruitingNCT01549730

University Health Network, Toronto30 enrolled

Overview

The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how cervix cancer grows and responds to treatments like radiotherapy and chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300 patients. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervix Cancer

Interventions

18F-Fluoroazomycin Arabinoside (18F-FAZA)PROCEDURE

A PET scan is an imaging test that uses special radioactive dyes to measure different aspects of how your cancer acts. In this study, a dye called 18F-Fluoroazomycin Arabinoside (18F-FAZA) will be used to measure hypoxia levels in tumours. Health Canada has not approved FAZA for general use, but has approved it for use in this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix * TNM (7th edition) cT1-4, N0-1, M0-1 * Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group * No cytotoxic anti-cancer therapy for cervix cancer prior to study entry * A negative urine or serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age * Ability to provide written informed consent to participate in the study Exclusion Criteria: * Prior complete or partial hysterectomy * Carcinoma of the cervical stump * Inability to lie supine for more than 30 minutes * Patients taking the drug disulfuram (Antabuse)

Locations (1)

Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Number of patients treated with the PET tracer FAZA to image primary tumor hypoxia in patients with cervix cancer prior to treatment with radiotherapy and concurrent cisplatin chemotherapy

Time frame: 2 years

Data from ClinicalTrials.gov

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