- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456137
Prospective Evaluation of Upright Versus Supine CT Myelography of the Lumbar Spine
June 3, 2026 updated by: Samuel Hund, University of Kansas Medical Center
The purpose of this prospective study is to compare the diagnostic utility of standing (upright, weight-bearing) CT myelography with standard supine CT myelography for the evaluation of lumbar central canal and neural foraminal stenoses.
This study aims to determine whether upright positioning provides additional diagnostic information in patients unable to undergo MRI, with the goal of improving assessment and management of degenerative lumbar spine disease.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- The University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years
- Outpatient status
- Scheduled for routine supine CT myelography
Exclusion Criteria:
- Inpatient status
- Prior lumbar spine surgical intervention or presence of metallic lumbar spinal hardware (thoracic or cervical spinal procedures are permitted)
- History of osseous metastatic disease involving the lumbar spine
- Acute traumatic injury involving the lumbar spine
- Pregnancy
- Participant body habitus exceeding the scanner's safe operational limits (e.g., gantry/bore size clearance, table weight capacity) as defined by the device manufacturer.
- Inability to tolerate CT scanning (e.g., severe pain, unable to stand independently for an extended period)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Upright and Supine CT Myelography
|
Upright CT Myelography
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does upright CT imaging change management plans for patients with lumbar spinal stenosis
Time Frame: 1 week
|
To determine whether upright CT imaging changes the management plan (yes or no) for patients with lumbar spinal stenosis.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spine measurements
Time Frame: 1 day
|
Objective measurements at different angles (mm) will be taken of the spine.
|
1 day
|
|
Severity grading of central canal stenosis
Time Frame: 1 day
|
Severity grading (mild, moderate, severe) of central canal stenosis in the spine.
|
1 day
|
|
Severity grading of neural foraminal stenosis
Time Frame: 1 day
|
Severity grading (mild, moderate, severe) of neural foraminal stenosis in the spine.
|
1 day
|
|
Presence or absence of nerve root compression
Time Frame: 1 day
|
Presence or absence of nerve root compression in the spine.
|
1 day
|
|
Presence or absence of disc bulges
Time Frame: 1 day
|
Presence or absence of disc bulges in the spine.
|
1 day
|
|
Presence or absence of herniations
Time Frame: 1 day
|
Presence or absence of herniations in the spine.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
March 3, 2026
First Posted (Actual)
March 6, 2026
Study Record Updates
Last Update Posted (Actual)
June 8, 2026
Last Update Submitted That Met QC Criteria
June 3, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00162088
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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