Investigation Into the Differentiation of Tumour and Healthy Brain Tissue Using Multi-exponential T2 Components
| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2008 | ||||
| Last Updated Date | April 4, 2012 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
T2 characteristics of glioma tissue versus normal [ Time Frame: Before radiotherapy treatment begins ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
T2 characteristics of glimoa tissue versus normal [ Time Frame: Before radiotherapy treatment begins ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00813787 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 Into the Differentiation of Tumour and Healthy Brain Tissue Using Multi-exponential T2 Components | ||||
| Official Title ICMJE | Investigation Into the Differentiation of Tumour and Healthy Brain Tissue Using a Specialized MRI Technique Called Multiexponential T2 Component Analysis | ||||
| Brief Summary | The purpose of this study is to see if a specialized imaging technique using MRI called multi-exponential T2 component analysis can reliably differentiate between normal brain and brain tumour. |
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| Detailed Description | Existing methods of contouring tumours for radiation therapy involve manual interpretations of qualitative diagnostic images. These methods, being qualitative, do not offer a consistent and reproducible platform for contouring, making it difficult to evaluate the effects of contouring choices on treatment outcome. T2 component analysis in MRI has the potential to offer a quantitive basis for identifying tumor tissue- this potential is investigated in this pilot study. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | A. Any glioma patient who recieves treatment at our clinic (Cross Cancer Institute) who agrees to take part in the study. B. Any normal volunteer who agrees to take part in the study. |
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| Condition ICMJE | Glioma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | May 2012 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00813787 | ||||
| Other Study ID Numbers ICMJE | CNS-24534 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alberta Health Services | ||||
| Study Sponsor ICMJE | Alberta Health Services | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Alberta Health Services | ||||
| Verification Date | April 2012 | ||||
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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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