Comparing two CT myelography methods for detecting CSF-venous fistulas in SIH
Official title: CSF-Venous Fistula Detection in Spontaneous Intracranial Hypotension: Comparative Diagnostic Yields of Energy Integrating Detector Versus Photon Counting Detector CT Myelography
Run by Duke University · NCT07582744 · Data updated 2026-11-12
This study tests whether the photon counting detector CT myelography (PCD-CTM) can find CSF-venous fistulas in spontaneous intracranial hypotension patients better than the standard energy integrating detector CT myelography (EID-CTM).
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | May 21, 2026 |
| Main results expected | June 2028 |
| Study ends | August 2028 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07582744 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with SIH and imaging findings suggesting CVF who can safely undergo both PCD-CTM and EID-CTM.
✕Probably not a fit
Patients whose CVFs are not more readily detected with PCD-CTM or who do not have CVFs may not benefit from the alternative imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Spontaneous intracranial hypotension (SIH) is often caused by spinal CSF leaks such as CSF-venous fistulas (CVFs). The trial prospectively compares two CT myelography techniques, PCD-CTM and EID-CTM, to see which yields higher CVF detection. Participants undergo both imaging methods, with results compared to guide potential curative treatment. Eligibility requires adults with SIH confirmed by imaging consistent with CVF risk factors. The study is led by Duke University with Siemens Healthineers as collaborators and is conducted at Duke University Medical Center.
Why it matters
Potential benefit: If PCD-CTM shows higher detection, patients may receive more accurate leak localization and potentially more effective treatment.
How similar studies have gone: Earlier retrospective studies suggested potential benefits of PCD-CTM for CVF detection, but prospective evidence is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Duke University Medical Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Timothy J Amrhein, MD — Duke University
- Study coordinator: Primary Clinical Research Coordinator
- Email: latonia.strader@duke.edu
- Phone: 919-684-7810
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.