An interventional study of PAUS imaging in Hydrocephalus in Infants and Hydrocephalus in Children, sponsored by Michael McDowell. Not yet recruiting. Open to participants aged 0 Days to 3 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Michael McDowell · Not applicable, Interventional, and Diagnostic
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:
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.
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.
190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.
This study's planned enrollment of 250 is above the median of 41 across 97 interventional studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →This is the only study on the registry with Michael McDowell as lead sponsor.
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Exclusion Criteria:
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
PAUS imaging will be conducted before and after hydrocephalus treatment procedures and, if applicable, during cerebrospinal removal procedures at the bedside.
PAUS Imaging Depth Prior to Hydrocephalus Treatment
Quantitative measurement of PAUS imaging depth (mm), obtained prior to surgery or other hydrocephalus treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
CSF Outflow Patency Prior to Hydrocephalus Treatment
Qualitative assessment of CSF outflow patency on PAUS imaging, obtained prior to surgery or other hydrocephalus treatment.
Time frame: During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.
CSF Outflow Patency Following Hydrocephalus Treatment
Qualitative assessment of CSF outflow patency on PAUS imaging, obtained following surgery or other hydrocephalus treatment.
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
Function of Cerebrospinal Fluid (CSF) Diversion Device
Qualitative assessment of CSF diversion device function on PAUS imaging, obtained following surgery or other hydrocephalus treatment.
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
PAUS Assessment of Hydrocephalus Resolution
Qualitative assessment of resolution of hydrocephalus on PAUS imaging, obtained following surgery or other hydrocephalus treatment.
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
PAUS Imaging Depth During Bedside Procedure
Quantitative measurement of PAUS imaging depth (mm), obtained during a temporizing bedside procedure such as lumbar puncture, Ommaya reservoir tap, or CSF removal through a previously placed external ventricular drain.
Time frame: During the bedside procedure.
PAUS Spatial Resolution During Bedside Procedure
Quantitative measurement of PAUS spatial resolution (mm), obtained during a temporizing bedside procedure such as lumbar puncture, Ommaya reservoir tap, or CSF removal through a previously placed external ventricular drain.
Time frame: During the bedside procedure.
PAUS Imaging Contrast During Bedside Procedure
Quantitative measurement of PAUS imaging contrast (dB), obtained during a temporizing bedside procedure such as lumbar puncture, Ommaya reservoir tap, or CSF removal through a previously placed external ventricular drain.
Time frame: During the bedside procedure.
No study locations are listed for this record.
Plan to share: No — Patient data will be coded.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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