The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00242073 |
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Recruitment Status
:
Completed
First Posted
: October 19, 2005
Last Update Posted
: September 21, 2017
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Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date ICMJE | October 18, 2005 | |||
| First Posted Date ICMJE | October 19, 2005 | |||
| Last Update Posted Date | September 21, 2017 | |||
| Study Start Date ICMJE | October 2001 | |||
| Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE | Not Provided | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT00242073 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 | The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer | |||
| Official Title ICMJE | The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer | |||
| Brief Summary | Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer | |||
| Detailed Description | Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Applicable | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE | Prostate Cancer | |||
| Intervention ICMJE | Procedure: MRI Prostate | |||
| Study Arms | 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 | |||
| Enrollment ICMJE | Not Provided | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date | August 2008 | |||
| Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00242073 | |||
| Other Study ID Numbers ICMJE | 02-0563-C | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | University Health Network, Toronto | |||
| Study Sponsor ICMJE | University Health Network, Toronto | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | University Health Network, Toronto | |||
| Verification Date | September 2017 | |||
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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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