CVFs in SIH: EID vs. PCD CTM

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07582744
Status
Recruiting
Apply to this trial

Conditions

  • Spontaneous Intracranial Hypotension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • photon counting detector CT myelography (PCD- CTM) — DIAGNOSTIC_TEST
    Randomization (1:1) to either photon counting detector CT myelography (PCD- CTM) or energy integrating detector CT myelography (EID-CTM)
  • energy integrating detector CT myelography (EID-CTM) — DIAGNOSTIC_TEST
    Randomization (1:1) to either photon counting detector CT myelography (PCD- CTM) or energy integrating detector CT myelography (EID-CTM)

Study Details

The purpose of this research study is to compare two types of Computed Tomography Myelography (CTM) scans, one on the photon counting detector scanner (called PCD-CTM) and the other on the energy integrating detector scanner (called EID-CTM); both of which doctors usually use to diagnose abnormal connections between the cerebrospinal fluid and the venous system, or CSF-venous fistulas. This study will help to see if the newer PCD-CTM scan can find more spinal fluid leaks \[CSF-venous fistulas (CVF)\] than the scan that is normally used (EID-CTM).

Key Dates

First listed
May 13, 2026
Start date
May 21, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Photon counting detector CT myelography (PCD-CTM)
  • Other: Energy integrating detector CT myelography (EID-CTM)

Primary Outcome Measure

Diagnostic Yield of CTM for CVF Detection Using DCCS [ Time Frame: Initial interpretation by radiologist performing procedure: within 4 weeks of completion of CTM. Secondary interpretation by additional neuroradiologist and adjudication by third (when needed): completion of study (approximately 3 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

Related Studies