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Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01281826
Recruitment Status : Unknown
Verified January 2011 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : January 24, 2011
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
National Cheng-Kung University Hospital

Tracking Information
First Submitted Date January 20, 2011
First Posted Date January 24, 2011
Last Update Posted Date February 11, 2011
Study Start Date January 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
Official Title Use of Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
Brief Summary

The purpose of this study is to

  1. Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image compared with MR imaging as standard reference.
  2. Evaluate parameters related to the BME of the collapsed vertebral body on DE CT virtual noncalcium images, such as the morphologic signs, visual qualitative detection, and quantitative values.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
Condition
  • Compression Fracture of Thoracic Vertebral Body
  • Spinal Compression Fracture
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January¬†21,¬†2011)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Compression fractures (thoracic and lumbar vertebrae)

Exclusion Criteria:

  • Age less than 18 years
  • Pregnancy
  • Any contraindications to MR imaging.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01281826
Other Study ID Numbers BR-99-093
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chien-Kuo Wang/Department of Diagnostic Radiology, National Cheng-Kung University Hospital
Study Sponsor National Cheng-Kung University Hospital
Collaborators Not Provided
Investigators
Study Chair: Chien-Kuo Wang Department of Diagnostic Radiology Cheng Kung University Medicial Center
PRS Account National Cheng-Kung University Hospital
Verification Date January 2011