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Cervix Hypoxia FAZA

This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01549730
First received: June 23, 2011
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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: 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)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549730

Contacts
Contact: Michael Milosevic, MD 416-946-4501 ext 6513 Michael.Milosevic@rmp.uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD     416-946-4501 ext 6513     Michael.Milosevic@rmp.uhn.on.ca    
Principal Investigator: Michael Milosevic, MD            
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Michael Milosevic, MD Princess Margaret Hospital, University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01549730     History of Changes
Other Study ID Numbers: 11-0026-C
Study First Received: June 23, 2011
Last Updated: December 14, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 16, 2013