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Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients

NCT07784179 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-08-25

No results posted yet for this study

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

  • Hydrocephalus in Infants
  • Hydrocephalus in Children

Interventions

DIAGNOSTIC_TEST

PAUS imaging

PAUS imaging will be conducted before and after hydrocephalus treatment procedures and, if applicable, during cerebrospinal removal procedures at the bedside.

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • Michael McDowell

    lead OTHER

Principal Investigators

  • Michael M McDowell, MD · Milton S. Hershey Medical Center

  • Sri-Rajasekhar Kothapalli, PhD · Penn State University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2029-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784179 on ClinicalTrials.gov