Cervix Hypoxia FAZA

Cervix Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01549730
• Other study ID #: UHN REB 11-0026-C
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2011
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cervix Cancer
• Hypoxia
• Uterine Cervical Neoplasms

Intervention

Procedure:
• 18F-Fluoroazomycin Arabinoside (18F-FAZA)
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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years