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Cervix Hypoxia FAZA

This study is currently recruiting participants.
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Verified December 2016 by University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: June 23, 2011
Last updated: December 28, 2016
Last verified: December 2016
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.

Condition Intervention
Cervix Cancer Procedure: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET FAZA imaging
PET FAZA imaging of tumor hypoxia in patients with cervix cancer
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01549730

Contact: Michael Milosevic, MD 416-946-4501 ext 2932

Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD    416-946-4501 ext 2932   
Principal Investigator: Michael Milosevic, MD         
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Michael Milosevic, MD Princess Margaret Hospital, University Health Network
  More Information

Responsible Party: University Health Network, Toronto Identifier: NCT01549730     History of Changes
Other Study ID Numbers: UHN REB 11-0026-C
Study First Received: June 23, 2011
Last Updated: December 28, 2016

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female processed this record on August 21, 2017