Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 20, 2011 | ||||
| Last Updated Date | February 9, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | December 2011 (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 NCT01281826 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 | Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures | ||||
| Official Title ICMJE | Use of Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures | ||||
| Brief Summary | The purpose of this study is to
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| Detailed Description | Patients with multiple compression fractures and in those with chronic fracture, determining which vertebra to treat is frequently difficult. In such patients, the treatment location is commonly determined from findings at imaging, which includes magnetic resonance (MR) imaging, bone scintigraphy, and computed tomography (CT). The bone marrow edema (BME) in acute/subacute VCFs is useful in determining the vertebra that is to be treated. MR imaging provides information on anatomic vertebral collapse and the loss of normal T1 high signal intensity from the marrow space of vertebrae with acute fractures. Loss of normal T1 high signal intensity indicates the presence of BME, which is the important sign for the PVP treatment of VCFs. Dual-energy (DE) CT has been used to create a virtual unenhanced scan by subtracting iodine from contrast agent-enhanced CT examinations.We expect that the same technique can be used to calculate a virtual noncalcium image from an unenhanced image, which makes bone marrow accessible for CT diagnosis. |
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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 | Patients are recruited from Department of Orthopedics between january 2011 and december 2011. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01281826 | ||||
| Other Study ID Numbers ICMJE | BR-99-093 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Chien-Kuo Wang/Department of Diagnostic Radiology, National Cheng-Kung University Hospital | ||||
| Study Sponsor ICMJE | National Cheng-Kung University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Cheng-Kung University Hospital | ||||
| Verification Date | January 2011 | ||||
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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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