Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques
Primary Purpose
Cervix Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CT and MRI with contrast
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervix Cancer
Eligibility Criteria
Inclusion Criteria: Cervix cancer intended for radiation therapy Exclusion Criteria: Contraindication to contrast enhanced MRI and CT Prior therapy for cervix cancer Prior pelvic radiation
Sites / Locations
- Princess Margaret HOspital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00242034
First Posted
October 18, 2005
Last Updated
September 2, 2008
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00242034
Brief Title
Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques
Official Title
Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
Brief Summary
In cervix cancer tumor oxygen levels and fluid pressure in the tumor have been shown to be related to patient outcome. Analysis of the way tumors enhance after intravenous contrast injection using MRI and CT can be used to determine parameters that relate to tumor blood vessels. In this study we hope to determine if there is a relationship between the enhancement of cervix cancer on MRI and CT and tumor oxygen levels and interstitial fluid pressure. If such a relationship exists then it could help improve the care of patients wiht cervix cancer by allowing for more aggressive therapy of patients with cancer that have more ominous imaging characteristics
Detailed Description
MRI is already used routinely in the radiation planning and staging of carcinoma of the cervix. Prognostic factors such as T-stage (local extent), tumor size and lymphadenopathy are routinely obtained from MRI, however some prognostic parameters can only be obtained invasively. Tumor oxygenation correlates with prognosis and response to treatment in patients undergoing radiotherapy for carcinoma of the cervix. Interstitial fluid pressure (IFP) has been shown to correlate with tumor oxygenation as well. Currently the only way to measure these parameters is by using an invasive technique which involves the placement of probes into the tumor and obtaining multiple measurements.
Recent studies have shown that a specific MRI pulse sequences may be able to measure the oxygenation in the microcirculation. A second way of assessing the tumor microvasculature and perfusion is based on the behavior of intravenous contrast agents routinely used in the MRI examination. Estimates of blood volume, and capillary permeability can be made by mathematically modeling the kinetics of an MRI contrast agent. Similar measurements can be performed with CT.
A total of 60 patients will be investigated. Additional images will be obtained from these patients after their routine MRI examination. One set of images is designed to measure a parameter that correlates with tumor oxygen levels. The second set of images will be obtained after the injection of intravenous contrast agent. Using mathematical models a number of parameters will be extracted and correlated with IFP and tumor oxygen measurements.
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
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
CT and MRI with contrast
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cervix cancer intended for radiation therapy
Exclusion Criteria:
Contraindication to contrast enhanced MRI and CT
Prior therapy for cervix cancer
Prior pelvic radiation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoom Haider, MD
Organizational Affiliation
University Health Network, Toronto
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
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Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques
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