Cervix Hypoxia FAZA
A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 29, 2026
April 1, 2026
16 years
June 23, 2011
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (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
2 years
Study Arms (1)
PET FAZA imaging
EXPERIMENTALPET FAZA imaging of tumor hypoxia in patients with cervix cancer
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Milosevic, MD
Princess Margaret Hospital, University Health Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
March 9, 2012
Study Start
May 1, 2011
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04