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Cervix Hypoxia FAZA

Primary Purpose

Cervix Cancer

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

18F-Fluoroazomycin Arabinoside (18F-FAZA)

About this trial

This is an interventional diagnostic trial for Cervix Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET FAZA imaging

Arm Description

PET FAZA imaging of tumor hypoxia in patients with cervix cancer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01549730

First Posted

June 23, 2011

Last Updated

April 5, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01549730

Brief Title

Cervix Hypoxia FAZA

Official Title

A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 2011 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervix Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PET FAZA imaging

Arm Type

Experimental

Arm Description

PET FAZA imaging of tumor hypoxia in patients with cervix cancer

Intervention Type

Procedure

Intervention Name(s)

18F-Fluoroazomycin Arabinoside (18F-FAZA)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Milosevic, MD

Organizational Affiliation

Princess Margaret Hospital, University Health Network

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Cervix Hypoxia FAZA

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