- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01549730
Cervix Hypoxia FAZA
April 5, 2023 updated by: University Health Network, Toronto
A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PET FAZA imaging
PET FAZA imaging of tumor hypoxia in patients with cervix cancer
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time 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 chemotherapy
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2011
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
June 23, 2011
First Submitted That Met QC Criteria
March 6, 2012
First Posted (Estimate)
March 9, 2012
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
April 5, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 11-0026-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on 18F-Fluoroazomycin Arabinoside (18F-FAZA)
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Medical University of ViennaUnknownUterine Cervical NeoplasmsAustria
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Institut CurieActive, not recruitingSkull Base Chordoma | Vertebral ChordomaFrance
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The Hospital for Sick ChildrenEnrolling by invitationRhabdomyosarcoma | Non-Rhabdo. Soft Tissue SarcomaCanada
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University of California, San FranciscoCompletedRefractory Plasma Cell Myeloma | Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Recurrent Plasma Cell Myeloma | Recurrent Malignant Neoplasm | Refractory Malignant Neoplasm | Recurrent High Grade B-Cell Lymphoma | Refractory High Grade B-Cell Lymphoma | Recurrent... and other conditionsUnited States
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AHS Cancer Control AlbertaUnknown
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AHS Cancer Control AlbertaWithdrawn
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University of AarhusDanish Head and Neck Cancer GroupCompletedCancer of the Head and NeckDenmark