A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

University Health Network, Toronto1 site in 1 country30 target enrollmentMay 2011

ConditionsCervix Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervix Cancer
Sponsor: University Health Network, Toronto
Enrollment: 30
Locations: 1
Primary Endpoint: 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
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

May 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

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)

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