A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Cervix Cancer
Both
Cervix Cancer
Trial Information
A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
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)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
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
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Michael Milosevic, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, University Health Network
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 11-0026-C
NCT ID:
NCT01549730
Start Date:
May 2011
Completion Date:
May 2013
Related Keywords:
- Cervix Cancer
- Uterine Cervical Neoplasms
- Anoxia
Name | Location |
|---|
