Cervix Hypoxia FAZA

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01549730
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 132
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Phase
Cervix Cancer	Procedure: 18F-Fluoroazomycin Arabinoside (18F-FAZA)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• 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)
• Actual Study Start Date: May 1, 2011
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

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.

Outcome Measures

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 [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

• Principal Investigator: Michael Milosevic, MD, Princess Margaret Hospital, University Health Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01549730
• Other Study ID Numbers: UHN REB 11-0026-C
• First Posted: Mar 9, 2012
• Last Update Posted: Oct 6, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Hypoxia; Fluoroazomycin arabinoside

Study Results

No Results Posted as of Oct 6, 2021