NCT07582744

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Aug 2028

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Spontaneous Intracranial Hypotension

Keywords

CSF-venous fistulaPhoton counting detector CT myelographyEnergy integrating detector myelography

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

Study Arms (2)

Photon counting detector CT myelography (PCD-CTM)

EXPERIMENTAL
Diagnostic Test: photon counting detector CT myelography (PCD- CTM)

Energy integrating detector CT myelography (EID-CTM)

OTHER
Diagnostic Test: energy integrating detector CT myelography (EID-CTM)

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)

Photon counting detector CT myelography (PCD-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)

Energy integrating detector CT myelography (EID-CTM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Intracranial Hypotension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Timothy J Amrhein, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Primary Clinical Research Coordinator

CONTACT

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

Clinical Research Specialist

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)