Spinal Cord Injury, Degenerative Spinal Disease.NCT01973257
Perfusion and Diffusion Mechanism of Intervertebral Disc-Significance With Age, Degeneration, Posture and Stress Loading.
A study testing imaging diagnostics in people with Spinal Cord Injury, Degenerative Spinal Disease., run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion ability by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image with ADC value measurement, and to determine the relationship between these data and the degeneration of IVDs, the different posture… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Degenerative Spinal Disease.
- What is being tested?
- imaging diagnostics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Jul 2010
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of spinal cord injury and degenerative spinal disease
- Normal volunteers
Who cannot join
- Patients with cancer and infection.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion ability by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image with ADC value measurement, and to determine the relationship between these data and the degeneration of IVDs, the different posture, and different stress-loading status.
- Being tested
- imaging diagnostics
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging diagnosticsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| select from the option menu | Experimental | select from the option menu Receives: Procedure: imaging diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disc Perfusion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startAug 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury, Degenerative Spinal Disease.Studies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Ting-Fang Shih, Principal investigator, Department of Medical Image, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973257
- Sponsor's protocol ID
- 200612091R
- Status last verified
- Oct 2013
- First submitted
- 24 Oct 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion and Diffusion Mechanism of Intervertebral Disc-Significance With Age, Degeneration, Posture and Stress Loading.
- ClinicalTrials.gov ID
- NCT01973257
- Acronym / sponsor ID
- 200612091R
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 31 Oct 2013 (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 our study is to evaluate the perfusion of the IVDs and their diffusion ability by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image with ADC value measurement, and to determine the relationship between these data and the degeneration of IVDs, the different posture, and different stress-loading status.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| select from the option menu | Experimental | Procedure: imaging diagnosticsselect from the option menu |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a diagnosis of spinal cord injury and degenerative spinal disease
- Normal volunteers
Key exclusion criteria (1 listed)
- Patients with cancer and infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaging diagnostics | Procedure or surgery | select from the option menu |
Primary outcome
Disc Perfusion
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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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.
Tiffany Ting-Fang Shih principal investigator
Department of Medical Image, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaging diagnostics in people with Spinal Cord Injury, Degenerative Spinal Disease., run by National Taiwan 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 Nov 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disc Perfusion (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 1 Nov 2013.