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

Compression Fracture of Thoracic Vertebral Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01281826
• Other study ID #: BR-99-093
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2011
• Last updated: February 9, 2011
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2011
• Source: National Cheng-Kung University Hospital
• Contact: Chien-Kuo Wang
• Phone: 886-6-2353535
• Email: n044206[@]mail.hosp.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Compression fractures (thoracic and lumbar vertebrae)

Exclusion Criteria:

• Age less than 18 years

• Pregnancy

• Any contraindications to MR imaging.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Compression Fracture of Thoracic Vertebral Body
• Fractures, Bone
• Fractures, Compression
• Spinal Compression Fracture

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan,