CVFs in SIH: EID vs. PCD CTM

ConditionSpontaneous Intracranial Hypotension

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDuke University

About this trial

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).

Eligibility criteria

Qualifiers

Adult patient,

Confirmed diagnosis of SIH using International Classification of Headache Disorders criteria (third edition), and

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).

Disqualifiers

Prior treatment of a CVF,

Inability to undergo both exams (EID-CTM and PCD-CTM) if needed for diagnosis,

Spine MRI demonstrating extradural CSF (confirming CSF leak type other than CVF), and

inability to provide informed consent.

Trial design

Treatments tested in this trial

photon counting detector CT myelography (PCD- CTM)
energy integrating detector CT myelography (EID-CTM)

Treatment groups

200 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

Siemens Healthineers

Collaborator

Source ClinicalTrials.gov