Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques
| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 2005 | ||||
| Last Updated Date | September 2, 2008 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00242034 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques | ||||
| Official Title ICMJE | Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques | ||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Cervix Cancer | ||||
| Intervention ICMJE | Procedure: CT and MRI with contrast | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00242034 | ||||
| Other Study ID Numbers ICMJE | 00-0152-C | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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