Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-3
SponsorMichael McDowell
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
PAUS imaging
Diagnostic testPAUS imaging will be conducted before and after hydrocephalus treatment procedures and, if applicable, during cerebrospinal removal procedures at the bedside.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: PAUS imagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Secondary outcomes
1
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.2
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.3
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.4
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael McDowell
Lead sponsor
Milton S. Hershey Medical Center
Sponsor institution
Penn State University
Collaborator
Source ClinicalTrials.gov
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