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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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)

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Photon counting detector CT myelography (PCD-CTM)Experimental treatment 1 intervention

Group B: Energy integrating detector CT myelography (EID-CTM)Other 1 intervention

Trial outcomes

Primary outcomes

Diagnostic Yield of CTM for CVF Detection Using DCCS

Diagnostic yield will be calculated in both arms as the fraction of patients in whom at least one definite CVF (DCCS 3) is identified. CTM images from both arms will be reviewed by the radiologist performing the procedure as part of routine standard of care, as well as one additional neuroradiologist. The presence or absence of a CVF will be classified according to the Duke CVF Confidence Score (DCCS). Disagreements will be adjudicated by a third neuroradiologist.

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Siemens Healthineers

Collaborator

Source ClinicalTrials.gov

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