CVFs in SIH: EID vs. PCD CTM

June 11, 2026 updated by: Duke University

CSF-Venous Fistula Detection in Spontaneous Intracranial Hypotension: Comparative Diagnostic Yields of Energy Integrating Detector Versus Photon Counting Detector CT Myelography

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Spontaneous intracranial hypotension (SIH) is a debilitating condition caused by a spinal CSF leak. One subtype of spinal CSF leak, the CSF-venous fistula (CVF), is a pathologic connection between the CSF-containing nerve root sleeve and an adjacent paraspinal vein. Identifying and localizing the CVF that causes SIH is a critical prerequisite to curative treatment. Visualizing CVFs requires high-quality myelography. Despite improvements in myelographic techniques, CVF identification remains challenging because they are diminutive structures and depend on identifying small volumes of contrast in a paraspinal vein, the "hyperdense paraspinal vein sign."

Compared with EID CT myelography (EID-CTM), PCD-CTM enables much higher spatial resolution and a greater contrast-to-noise ratio, carrying with it the promise of improved detection rates for CVF. Previous publications report early encouraging findings on the benefits of PCD-CTM for CVF detection; however, all prior work has been based on retrospective data. Importantly, these retrospective studies have been biased toward reduced PCD-CTM CVF detection, since only the patients with CVFs that are not definitely identified on EID-CTM undergo PCD-CTM (thus, more challenging cases are completed on the PCD CT). No studies have prospectively demonstrated the additional benefit of PCD-CTM over EID-CTM. Furthermore, no studies have prospectively reported the yield of any type of myelography for CVF detection. Based on the study team's knowledge of these imaging modalities and the imaging appearance of CVFs, PCD-CTM may have a benefit in detecting CVFs that can be missed on EID-CTM, which has been suggested in retrospective studies.

This is a prospective randomized clinical trial designed to assess the diagnostic yield of two different CT scanner types for detecting CSF-venous fistulas (CVFs) during CT myelography. The primary study aim is to compare PCD-CTM to traditional EID-CTM, which is currently the most commonly used technique for CVF detection. Patients meeting inclusion/exclusion criteria will be identified at the Duke CSF Leak Clinic. After informed consent, enrolled participants will be randomized (1:1 allocation) to either PCD-CTM or EID-CTM. CTM technique for both arms will be performed in a standardized manner as part of routine standard of care, as previously published. There will be no additional imaging outside of the current standard of care.

The only intervention in this study is randomization into either of the two imaging arms.

CTM images 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Photon counting detector CT myelography (PCD-CTM)
Diagnostic test: 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)
Other: Energy integrating detector CT myelography (EID-CTM)
Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Siemens Healthineers

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy J Amrhein, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00118497

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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