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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 6, 2007 | ||||
| Last Updated Date | July 7, 2009 | ||||
| Start Date ICMJE | August 2004 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
MRIs of diffusion (the random motion of molecules) and fat [ Time Frame: One extra 10 minute MRI sequence during scheduled spine exam. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The goal of this clinical research study is to find out if the combination of quantitative diffusion and fat MRI techniques can tell the difference between spinal fractures that are caused by cancer and those that are not. [ Time Frame: 68 Months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00498277 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quantitative Diffusion and Fat Imaging of the Spine | ||||
| Official Title ICMJE | Quantitative Diffusion and Fat Imaging of Vertebral Fractures | ||||
| Brief Summary | Primary Objective: The purpose of this study is to determine whether or not combined quantitative diffusion and fat MR imaging techniques can differentiate between benign and malignant vertebral fractures. |
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| Detailed Description | Researchers believe that they may be able to use MRI scans to tell if fractures of the bones in the spine are due to cancer. They believe this can be done by looking at MRIs of diffusion (the random motion of molecules) and fat. For benign and malignant processes, either diffusion or fat, or both of them, can be different, because the cell density (which affects diffusion) and bone marrow content (which affects fat) are expected to be different. All patients in this study will have already been scheduled for MRI exams of the spine at UTMDACC. You will have one extra MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion. The extra time required for the study should be less than 10 minutes, and the total imaging time should fall within a standard MRI time slot. Available data from your medical record, including imaging data, will be used to set up guidelines and clear examples for checking spinal fractures. This is an investigational study. A total of 48 patients will take part in the study. All will be enrolled at UTMDACC. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Osteoporosis | ||||
| Intervention ICMJE | Procedure: Magnetic Resonance Imaging | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 21 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1. Patients with suspected vertebral compression fractures scheduled a standard of care MRI of the spine. Exclusion Criteria:
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| Gender | Both | ||||
| 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 | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00498277 | ||||
| Responsible Party | Jingfei Ma, PhD/Associate Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2004-0317 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | July 2009 | ||||
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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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