Recruiting

PCD-CTM vs. EID-CTM

Sponsor:

Duke University

Code:

NCT07582744

Conditions

Spontaneous Intracranial Hypotension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

photon counting detector CT myelography (PCD- CTM)

energy integrating detector CT myelography (EID-CTM)

Study Details

Brief summary:

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).

Conditions

Spontaneous Intracranial Hypotension

Study ID

NCT07582744

Start date

May 21, 2026

Status verified date

May, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patient,
2. Confirmed diagnosis of SIH using International Classification of Headache Disorders criteria (third edition), and
3. Brain MRI demonstrating at least one positive imaging finding for SIH (e.g., dural enhancement, venous sinus distention, brain sagging, pituitary engorgement, spontaneous subdural fluid collections).

Exclusion Criteria:

1. Prior treatment of a CVF,
2. Inability to undergo both exams (EID-CTM and PCD-CTM) if needed for diagnosis,
3. Spine MRI demonstrating extradural CSF (confirming CSF leak type other than CVF), and
4. inability to provide informed consent.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Photon counting detector CT myelography (PCD-CTM)

other: Energy integrating detector CT myelography (EID-CTM)

Interventions

photon counting detector CT myelography (PCD- CTM)

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)

Randomization (1:1) to either photon counting detector CT myelography (PCD- CTM) or 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 and Locations

Central contacts

Primary Clinical Research Coordinator

919-684-7810latonia.strader@duke.edu

Clinical Research Specialist

919-684-3296amy.cuddington@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

More Information

Sponsor

Duke University

Last update posted

Jun 15, 2026

Last verified

May, 2026

Keywords

  • CSF-venous fistula
  • Photon counting detector CT myelography
  • Energy integrating detector myelography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-15.