Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00242034
Collaborator
(none)
60
1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: CT and MRI with contrast
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    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: Masoom Haider, MD, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00242034
    Other Study ID Numbers:
    • 00-0152-C
    First Posted:
    Oct 19, 2005
    Last Update Posted:
    Sep 3, 2008
    Last Verified:
    Aug 1, 2008
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 3, 2008