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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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01549730
Enrollment
30
Registered
2012-03-09
Start date
2011-05-01
Completion date
2027-05-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Cancer

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.

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.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
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 chemotherapy2 years

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORMichael Milosevic, MD

Princess Margaret Hospital, University Health Network

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026