Spontaneous Intracranial HypotensionNCT07582744
CVFs in SIH: EID vs. PCD CTM
A study testing photon counting detector CT myelography (PCD- CTM) and energy integrating detector CT myelography (EID-CTM) in people with Spontaneous Intracranial Hypotension, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Intracranial Hypotension
- What is being tested?
- photon counting detector CT myelography (PCD- CTM) and energy integrating detector CT myelography (EID-CTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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).
Read the 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.
- Conditions
- Spontaneous Intracranial Hypotension
- Being tested
- photon counting detector CT myelography (PCD- CTM), energy integrating detector CT myelography (EID-CTM)
- Keywords
- CSF-venous fistula, Photon counting detector CT myelography, Energy integrating detector myelography
- Medical subject headings
- Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Photon counting detector CT myelography (PCD-CTM) | Experimental | Not described Receives: Diagnostic Test: photon counting detector CT myelography (PCD- CTM) |
| Energy integrating detector CT myelography (EID-CTM) | Other | Not described Receives: Diagnostic Test: energy integrating detector CT myelography (EID-CTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start21 May 2026
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intracranial HypotensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthineers
- Responsible party
- Sponsor
- Investigators
- Timothy J Amrhein, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582744
- Sponsor's protocol ID
- Pro00118497
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSF-Venous Fistula Detection in Spontaneous Intracranial Hypotension: Comparative Diagnostic Yields of Energy Integrating Detector Versus Photon Counting Detector CT Myelography
- ClinicalTrials.gov ID
- NCT07582744
- Acronym / sponsor ID
- Pro00118497
- Conditions
- Spontaneous Intracranial Hypotension
- Keywords
- CSF-venous fistula, Photon counting detector CT myelography, Energy integrating detector myelography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Siemens Healthineers
- Study start
- 21 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Diagnostic test | Photon counting detector CT myelography (PCD-CTM) |
| 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) | Diagnostic test | Energy integrating detector CT myelography (EID-CTM) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy J Amrhein, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photon counting detector CT myelography (PCD- CTM) and energy integrating detector CT myelography (EID-CTM) in people with Spontaneous Intracranial Hypotension, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Primary Clinical Research Coordinator (919-684-7810, latonia.strader@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.