Compression Fracture of Thoracic Vertebral BodyNCT01281826
Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
An observational study of Compression Fracture of Thoracic Vertebral Body and Spinal Compression Fracture, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Compression Fracture of Thoracic Vertebral Body, Spinal Compression Fracture
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited from Department of Orthopedics between january 2011 and december 2011.
Who may be able to join
- Compression fractures (thoracic and lumbar vertebrae)
Who cannot join
- Age less than 18 years
- Pregnancy
- Any contraindications to MR imaging.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan
Chien-Kuo Wang, 886-6-2353535 ext. 2491, n044206@mail.hosp.ncku.edu.tw
About this study
Official title: Use of Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
The purpose of this study is to
- Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image compared with MR imaging as standard reference.
- 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.
Read the 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compression Fracture of Thoracic Vertebral BodyStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chien-Kuo Wang, Study chair, Department of Diagnostic Radiology Cheng Kung University Medicial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281826
- Sponsor's protocol ID
- BR-99-093
- Status last verified
- Jan 2011
- First submitted
- 20 Jan 2011
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
- ClinicalTrials.gov ID
- NCT01281826
- Acronym / sponsor ID
- BR-99-093
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to
- Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image compared with MR imaging as standard reference.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from Department of Orthopedics between january 2011 and december 2011.
Key inclusion criteria (1 listed)
- Compression fractures (thoracic and lumbar vertebrae)
Key exclusion criteria (3 listed)
- Age less than 18 years
- Pregnancy
- Any contraindications to MR imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Kuo Wang study chair
Department of Diagnostic Radiology Cheng Kung University Medicial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compression Fracture of Thoracic Vertebral Body and Spinal Compression Fracture, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Kuo Wang (886-6-2353535 ext. 2491, n044206@mail.hosp.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.