Cervix Hypoxia FAZA

NCT ID: NCT01549730

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2026-05-31

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.

Conditions

Cervix Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET FAZA imaging

PET FAZA imaging of tumor hypoxia in patients with cervix cancer

Group Type: EXPERIMENTAL

18F-Fluoroazomycin Arabinoside (18F-FAZA)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Milosevic, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, University Health Network

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 11-0026-C

Identifier Type: -

Identifier Source: org_study_id