Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients | NCT07784179 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 25, 2026

Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients

Ultrasound and Photoacoustic Imaging of Hydrocephalus

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07784179
Lead Sponsor: Michael McDowellOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 250Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Sep 2028Estimated
Completion Date: Sep 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Ultrasound and Photoacoustic Imaging of Hydrocephalus
Brief Summary: The goal of this study is to out find out the capabilities and limitations of the combined photoacoustic and ultrasound (PAUS) imaging device for diagnosing hydrocephalus in children. The main questions it aims to answer are:

can PAUS imaging allow for new and better ways to rapidly diagnose hydrocephalus?

Can PAUS imaging be used to confirm that treatments for hydrocephalus are working? PAUS imaging has been FDA approved for other medical conditions, but this is the first study to evaluate it for hydrocephalus detection.

Participants will undergo imaging through the anterior fontanelle with the dual-mode PAUS imaging device. Each imaging session will take about 30 to 60 minutes. These sessions will take place once before and once after hydrocephalus treatment, as the participant is willing. In some cases, if a patient is having cerebrospinal fluid removed at the bedside, an additional imaging session will occur to monitor the procedure in real-time, if the participant is willing.

Conditions

The medical conditions and diseases this study investigates.

Hydrocephalus in Infants
Hydrocephalus in Children

Interventions

The treatments and procedures being evaluated in this study.

PAUS imaging

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Diagnosis of hydrocephalus by a neurosurgeon

Age ≤ 3 years

Admitted to Penn State Health Children's Hospital with plans for definitive hydrocephalus treatment while inpatient, including shunt placement surgery, endoscopic third ventriculostomy, shunt revision, external ventricular drain placement.

Exclusion Criteria:

Age > 3 years

No open anterior fontanelle or fontanelle is obstructed for clinical purposes

Too unstable to undergo diagnostic testing equivalents (i.e. standard ultrasonography)

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Michael M McDowell, MDContact

mmcdowell1@pennstatehealth.psu.edu717-531-7123

Locations

Where the study is run and whether each site is currently recruiting.

No locations

There are no locations for this study.

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Michael McDowellOTHER
Collaborators

Similar Studies

Other registered studies that closely resemble this one.

The goal of this research study is to understand the capabilities of the photoacoustic ultrasound (PAUS) imaging device for hydrocephalus detection. For each subject, the PAUS imaging of CSF fluid will be performed. From the obtained imaging data, such as patency of CSF outflow, function of CSF diversion devices, and resolution of symptomatic hydrocephalus will be quantified to serve as potential hydrocephalus diagnostic biomarkers. For this purpose, each of these biomarkers will be compared with available standard test results such as MRA, XRA and ultrasound blood flow measurements. In addition, the imaging data will be used to study the changes in imaging depth, spatial resolution and contrast across different patients.

A total of 250 hydrocephalus patients will be recruited and imaged at the Penn State Children's Hospital Hershey campus.

The clinical staff at Hershey will use the available hydrocephalus medical records of patients admitted to Penn State Children's Hospital to confirm their eligibility. Before imaging, the parent/guardian of the patient will be informed through consent process that the clinical staff will have access to their medical records.

All subjects will be imaged at rest using the PAUS system that provides multiparametric photoacoustic imaging metrics. This will be done once prior to each surgery/hydrocephalus treatment and once afterwards provided it does not interfere with patient care. Each measurement will be obtained no more than 7 days from the time of treatment. Patients undergoing repetitive, temporizing procedures (serial lumbar punctures, reservoir taps) at the bedside will have the opportunity to participate in real time measurement of the effect of the procedure while it is happening. This will be a secondary component of the study that will be specifically consented for in patients that this is the case. Refusal of this portion of the study will not prevent involvement in the other parts. These results will be quantitatively evaluated and tabulated for each recruited patient, along with the standard test results such as fontanelle fullness and occipito-frontal circumference as well as any other non-imaging and imaging results available for the patient's neurologic health.

These initial pilot studies on 250 hydrocephalus patients at Penn State will help provide preliminary data for ultimately demonstrating clinical effectiveness of this technology.