Prospective Evaluation of Upright Versus Supine CT Myelog... | NCT07456137

Studies
Prospective Evaluation of Upright Versus Supine CT Myelography of the Lumbar Spine

NCT07456137

Sponsor

University of Kansas Medical Center

Status

Enrolling by invitation

Last Update Posted

Jul 10, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Lumbar Central Canal Stenoses
Neural Foraminal Stenoses

Interventions

Upright CT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 13, 2025

First Submission Date that Met QC Criteria

Mar 3, 2026

First Posted Date

Mar 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2026

Last Update Posted Date

Jul 10, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samuel Hund, MD, Assistant Professor, University of Kansas Medical CenterPrincipal Investigator

Lead Sponsor

University of Kansas Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Upright and Supine CT Myelography	Other	Upright and Supine CT Myelography	Radiation: Upright CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Upright CT	Radiation	Upright CT Myelography	Upright and Supine CT Myelography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Does upright CT imaging change management plans for patients with lumbar spinal stenosis	To determine whether upright CT imaging changes the management plan (yes or no) for patients with lumbar spinal stenosis.	1 week

Secondary Outcomes

Measure	Description	Time Frame
Spine measurements	Objective measurements at different angles (mm) will be taken of the spine.	1 day
Severity grading of central canal stenosis	Severity grading (mild, moderate, severe) of central canal stenosis in the spine.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Outpatient status
Scheduled for routine supine CT myelography

Exclusion Criteria:

Inpatient status
Presence of metallic lumbar spinal hardware
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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Kansas Medical Center		Kansas City	Kansas	66160	United States