200 Participants NeededMy employer runs this trial

CT Myelography Scans for Intracranial Hypotension

PC
CR
Overseen ByClinical Research Specialist
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of CT scans used to detect spinal fluid leaks, which can lead to spontaneous intracranial hypotension (SIH). The researchers seek to determine if a new scan method, Photon Counting Detector CT Myelography (PCD-CTM), can identify more leaks than the older method, Energy Integrating Detector CT Myelography (EID-CTM). Eligible participants should be adults with SIH confirmed by specific brain MRI findings, such as brain sagging or abnormal fluid collections. As an unphased trial, this study offers an opportunity to contribute to advancing diagnostic methods for SIH.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these CT myelography scans are safe?

Research has shown that Photon Counting Detector CT Myelography (PCD-CTM) is generally safe for individuals needing scans for cerebrospinal fluid (CSF) issues. Studies have found that PCD-CTM uses less radiation than the traditional method, Energy Integrating Detector CT Myelography (EID-CTM), reducing radiation exposure during the scan. Specifically, one study found that the radiation dose with PCD-CTM was about 65% lower than with EID-CTM.

While the lower radiation is beneficial, it's important to note that both types of CT scans are commonly used in medical settings, indicating they are generally well-tolerated by most individuals. However, like any medical procedure, there is a chance of side effects, though serious problems are rare. Always discuss any concerns with the trial staff or your doctor.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring two cutting-edge CT myelography techniques, Photon Counting Detector CT Myelography (PCD-CTM) and Energy Integrating Detector CT Myelography (EID-CTM), to better diagnose intracranial hypotension. Unlike traditional imaging methods, PCD-CTM offers enhanced image quality and higher resolution, potentially leading to more accurate detection of cerebrospinal fluid leaks. EID-CTM, on the other hand, provides a detailed view of the spinal canal using advanced energy integration, which can improve diagnostic confidence. These innovations could revolutionize how intracranial hypotension is diagnosed, offering quicker and more precise insights.

What evidence suggests that these CT myelography scans are effective for detecting CSF-venous fistulas?

This trial will compare two types of CT myelography scans for detecting cerebrospinal fluid (CSF) leaks in patients with intracranial hypotension. Research has shown that Photon Counting Detector CT Myelography (PCD-CTM), one of the methods tested in this trial, outperforms the older method, Energy Integrating Detector CT Myelography (EID-CTM), which is also under evaluation. Studies indicate that PCD-CTM is more sensitive, detecting more leaks; for instance, one study found that PCD-CTM identified 16% more leaks than EID-CTM. It also provides clearer images, aiding in more accurate diagnoses, and uses less radiation, enhancing patient safety. This makes PCD-CTM a promising method for detecting leaks in patients with low brain pressure.13467

Who Is on the Research Team?

TJ

Timothy J Amrhein, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with spontaneous intracranial hypotension (SIH) who have specific signs of the condition on a brain MRI, such as fluid buildup or changes in brain structures.

Inclusion Criteria

I am an adult.
My brain MRI shows signs of spontaneous intracranial hypotension (SIH).
I have been diagnosed with SIH based on standard headache disorder criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Imaging

Participants are randomized to either PCD-CTM or EID-CTM imaging arms and undergo CT myelography

1 day
1 visit (in-person)

Initial Interpretation

Initial interpretation of CTM images by the radiologist performing the procedure

4 weeks

Secondary Interpretation and Adjudication

Secondary interpretation by an additional neuroradiologist and adjudication by a third neuroradiologist if needed

Up to 3 years

Follow-up

Participants are monitored for any adverse events and outcomes related to the imaging procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Energy Integrating Detector CT Myelography
  • Photon Counting Detector CT Myelography

Trial Overview

The study compares two types of CT myelography scans—one using a newer photon counting detector (PCD-CTM), and the other using the standard energy integrating detector (EID-CTM)—to see which better detects spinal fluid leaks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Photon counting detector CT myelography (PCD-CTM)Experimental Treatment1 Intervention
Group II: Energy integrating detector CT myelography (EID-CTM)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Siemens Healthineers

Collaborator

Trials
2
Recruited
2,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38294163/

Myelography Using Energy-Integrating Detector CT ... - PubMed

This purpose of this study was to compare energy-integrating detector (EID) CT myelography and photon-counting detector (PCD) CT myelography in terms of image ...

Myelography Using Energy-Integrating Detector CT Versus ...

This purpose of this study was to compare energy-integrating detector (EID) CT myelography and photon-counting detector (PCD) CT myelography in terms of image ...

Benefits of Photon-Counting CT Myelography for ...

Photon-counting CT myelography was described as an effective technique for the detection of CSF-venous fistulas, a common cause of spontaneous intracranial ...

PCD-CT for Early Detection of Spontaneous Intracranial ...

Research suggests that PCD-CT myelography could facilitate earlier diagnosis of spontaneous intracranial hypotension (SIH).

Photon-Counting Detector vs. Energy-Integrating Detector CT ...

RESULTS: Session DLP was significantly lower for PCD-CTM than for EID-CTM: 1760 (1277-2206) vs 5030 (3476-6559) mGy·cm (median reduction, 65.0%; ...

Photon-Counting Detector vs. Energy-Integrating ...

CONCLUSIONS: In patients undergoing CT myelography for CVF evaluation, PCD-CTM was associated with an approximately 65% lower session-level ...

Photon Counting CT May Facilitate Earlier Diagnosis of ...

The researchers also found that sensitivity rates for PCD-CT myelography were 16 percent higher on average (58 percent) than EID-CT myelography ...