Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients

NCT07784179 | Not Yet Recruiting

• 1 other identifier: STUDY00027200
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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

Hydrocephalus in Infants; Hydrocephalus in Children

Keywords

Hydrocephalus; Photoacoustic Ultrasound Imaging; PAUS Imaging

Outcome Measures

Primary Outcomes (6)

• PAUS Imaging Depth Prior to Hydrocephalus Treatment

  Quantitative measurement of PAUS imaging depth (mm), obtained prior to surgery or other hydrocephalus treatment.

  During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.

• PAUS Imaging Depth Following Hydrocephalus Treatment

  Quantitative measurement of PAUS imaging depth (mm), obtained following surgery or other hydrocephalus treatment.

  During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.

• PAUS Spatial Resolution Prior to Hydrocephalus Treatment

  Quantitative measurement of PAUS spatial resolution (mm), obtained prior to surgery or other hydrocephalus treatment.

  During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.

• PAUS Spatial Resolution Following Hydrocephalus Treatment

  Quantitative measurement of PAUS spatial resolution (mm), obtained following surgery or other hydrocephalus treatment.

  During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.

• PAUS Imaging Contrast Prior to Hydrocephalus Treatment

  Quantitative measurement of PAUS imaging contrast (dB), obtained prior to surgery or other hydrocephalus treatment.

  During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.

• PAUS Imaging Contrast Following Hydrocephalus Treatment

  Quantitative measurement of PAUS imaging contrast (dB), obtained following surgery or other hydrocephalus treatment.

  During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.

Secondary Outcomes (7)

• CSF Outflow Patency Prior to Hydrocephalus Treatment

  During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.

• CSF Outflow Patency Following Hydrocephalus Treatment

  During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.

• Function of Cerebrospinal Fluid (CSF) Diversion Device

  During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.

• PAUS Assessment of Hydrocephalus Resolution

  During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.

• PAUS Imaging Depth During Bedside Procedure

  During the bedside procedure.

Study Arms (1)

PAUS imaging

EXPERIMENTAL

Patients in this arm will undergo PAUS imaging before and after hydrocephalus treatment procedures and, if applicable, during cerebrospinal removal procedures at the bedside.

Diagnostic Test: PAUS imaging

Interventions

PAUS imaging DIAGNOSTIC_TEST

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

PAUS imaging

Eligibility Criteria

• Age: 0 Days - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michael McDowell: lead
• Penn State University: collaborator

Related Publications (14)

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• Agrawal S, Johnstonbaugh K, Clark JY, Raman JD, Wang X, Kothapalli SR. Design, Development, and Multi-Characterization of an Integrated Clinical Transrectal Ultrasound and Photoacoustic Device for Human Prostate Imaging. Diagnostics (Basel). 2020 Aug 7;10(8):566. doi: 10.3390/diagnostics10080566.

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MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michael M McDowell, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

• Sri-Rajasekhar Kothapalli, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael M McDowell, MD

CONTACT

717-531-7123; mmcdowell1@pennstatehealth.psu.edu

Ryan S Biskowitz, BS

CONTACT

484-999-1614; rbiskowitz@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Neurosurgery

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share