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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Cheng-Kung University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01281826
First received: January 20, 2011
Last updated: February 9, 2011
Last verified: January 2011
  Purpose

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.

Condition
Compression Fracture of Thoracic Vertebral Body
Spinal Compression Fracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Estimated Enrollment: 70
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are recruited from Department of Orthopedics between january 2011 and december 2011.

Criteria

Inclusion Criteria:

  • Compression fractures (thoracic and lumbar vertebrae)

Exclusion Criteria:

  • Age less than 18 years
  • Pregnancy
  • Any contraindications to MR imaging.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281826

Contacts
Contact: Chien-Kuo Wang 886-6-2353535 ext 2491 n044206@mail.hosp.ncku.edu.tw

Locations
Taiwan
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Chien-Kuo Wang    886-6-2353535 ext 2491    n044206@mail.hosp.ncku.edu.tw   
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Study Chair: Chien-Kuo Wang Department of Diagnostic Radiology Cheng Kung University Medicial Center
  More Information

No publications provided

Responsible Party: Chien-Kuo Wang/Department of Diagnostic Radiology, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01281826     History of Changes
Other Study ID Numbers: BR-99-093
Study First Received: January 20, 2011
Last Updated: February 9, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Compression
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014