Cervix Hypoxia FAZA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01549730
Recruitment Status : Recruiting
First Posted : March 9, 2012
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Cervix Cancer Procedure: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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)
Study Start Date : May 2011
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University Health Network, Toronto Identifier: NCT01549730     History of Changes
Other Study ID Numbers: UHN REB 11-0026-C
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Signs and Symptoms, Respiratory
Signs and Symptoms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female