Cervix Hypoxia FAZA

Not Applicable

Active, not recruiting

• Conditions: Cervix Cancer
• Interventions: Procedure: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

• Registration Number: NCT01549730
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET FAZA imaging	18F-Fluoroazomycin Arabinoside (18F-FAZA)	PET FAZA imaging of tumor hypoxia in patients with cervix cancer

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada