Hydrocephalus in InfantsNCT07784179
Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients
A study testing PAUS imaging in people with Hydrocephalus in Infants and Hydrocephalus in Children, run by Michael McDowell.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 3 years
- Conditions the study is for
- Hydrocephalus in Infants, Hydrocephalus in Children
- What is being tested?
- PAUS imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound and Photoacoustic Imaging of Hydrocephalus
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.
Read the detailed description
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.
- Being tested
- PAUS imaging
- Keywords
- Hydrocephalus, Photoacoustic Ultrasound Imaging, PAUS Imaging
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAUS imagingDiagnostic test
PAUS imaging will be conducted before and after hydrocephalus treatment procedures and, if applicable, during cerebrospinal removal procedures at the bedside.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: PAUS imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAUS Imaging Depth Prior to Hydrocephalus Treatment
Quantitative measurement of PAUS imaging depth (mm), obtained prior to surgery or other hydrocephalus treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
Secondary outcomes (7)
CSF Outflow Patency Prior to Hydrocephalus Treatment
Qualitative assessment of CSF outflow patency on PAUS imaging, obtained prior to surgery or other hydrocephalus treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the bedside procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus in InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael McDowell
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Sponsor-investigator, Michael McDowell, Milton S. Hershey Medical Center
- Investigators
- Michael M McDowell, MD, Principal investigator, Milton S. Hershey Medical CenterSri-Rajasekhar Kothapalli, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784179
- Sponsor's protocol ID
- STUDY00027200
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be coded.
Publications
Steinberg I, Huland DM, Vermesh O, Frostig HE, Tummers WS, Gambhir SS. Photoacoustic clinical imaging. Photoacoustics. 2019 Jun 8;14:77-98. doi: 10.1016/j.pacs.2019.05.001. eCollection 2019 Jun.
PubMed 31293884Wang LV, Hu S. Photoacoustic tomography: in vivo imaging from organelles to organs. Science. 2012 Mar 23;335(6075):1458-62. doi: 10.1126/science.1216210.
PubMed 22442475Lin L, Hu P, Shi J, Appleton CM, Maslov K, Li L, Zhang R, Wang LV. Single-breath-hold photoacoustic computed tomography of the breast. Nat Commun. 2018 Jun 15;9(1):2352. doi: 10.1038/s41467-018-04576-z.
PubMed 29907740Zhang HF, Maslov K, Stoica G, Wang LV. Functional photoacoustic microscopy for high-resolution and noninvasive in vivo imaging. Nat Biotechnol. 2006 Jul;24(7):848-51. doi: 10.1038/nbt1220. Epub 2006 Jun 25.
PubMed 16823374Galanzha EI, Menyaev YA, Yadem AC, Sarimollaoglu M, Juratli MA, Nedosekin DA, Foster SR, Jamshidi-Parsian A, Siegel ER, Makhoul I, Hutchins LF, Suen JY, Zharov VP. In vivo liquid biopsy using Cytophone platform for photoacoustic detection of circulating tumor cells in patients with melanoma. Sci Transl Med. 2019 Jun 12;11(496):eaat5857. doi: 10.1126/scitranslmed.aat5857.
PubMed 31189720Reber J, Willershauser M, Karlas A, Paul-Yuan K, Diot G, Franz D, Fromme T, Ovsepian SV, Beziere N, Dubikovskaya E, Karampinos DC, Holzapfel C, Hauner H, Klingenspor M, Ntziachristos V. Non-invasive Measurement of Brown Fat Metabolism Based on Optoacoustic Imaging of Hemoglobin Gradients. Cell Metab. 2018 Mar 6;27(3):689-701.e4. doi: 10.1016/j.cmet.2018.02.002.
PubMed 29514074Dasa MK, Markos C, Maria M, Petersen CR, Moselund PM, Bang O. High-pulse energy supercontinuum laser for high-resolution spectroscopic photoacoustic imaging of lipids in the 1650-1850 nm region. Biomed Opt Express. 2018 Mar 20;9(4):1762-1770. doi: 10.1364/BOE.9.001762. eCollection 2018 Apr 1.
PubMed 29675317Allen TJ, Hall A, Dhillon AP, Owen JS, Beard PC. Spectroscopic photoacoustic imaging of lipid-rich plaques in the human aorta in the 740 to 1400 nm wavelength range. J Biomed Opt. 2012 Jun;17(6):061209. doi: 10.1117/1.JBO.17.6.061209.
PubMed 22734739Xu Z, Li C, Wang LV. Photoacoustic tomography of water in phantoms and tissue. J Biomed Opt. 2010 May-Jun;15(3):036019. doi: 10.1117/1.3443793.
PubMed 20615021Yan Y, Gomez-Lopez N, Basij M, Shahvari AV, Vadillo-Ortega F, Hernandez-Andrade E, Hassan SS, Romero R, MehrMohammadi M. Photoacoustic imaging of the uterine cervix to assess collagen and water content changes in murine pregnancy. Biomed Opt Express. 2019 Aug 19;10(9):4643-4655. doi: 10.1364/BOE.10.004643. eCollection 2019 Sep 1.
PubMed 31565515Paulus LP, Buehler A, Wagner AL, Raming R, Jungert J, Simon D, Tascilar K, Schnell A, Rother U, Eckstein M, Lang W, Hoerning A, Schett G, Neurath MF, Waldner MJ, Trollmann R, Woelfle J, Bohndiek SE, Regensburger AP, Knieling F. Contrast-Enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Tract. Adv Sci (Weinh). 2023 Aug;10(23):e2302562. doi: 10.1002/advs.202302562. Epub 2023 Jun 8.
PubMed 37289088Manwar R, Kratkiewicz K, Mahmoodkalayeh S, Hariri A, Papadelis C, Hansen A, Pillers DM, Gelovani J, Avanaki K. Development and characterization of transfontanelle photoacoustic imaging system for detection of intracranial hemorrhages and measurement of brain oxygenation: Ex-vivo. Photoacoustics. 2023 Jul 27;32:100538. doi: 10.1016/j.pacs.2023.100538. eCollection 2023 Aug.
PubMed 37575972Srivastava S, Yu B, Giraud D, Dighe M, Dhyani M, Barr RG. Overview of Diagnostic Ultrasound Safety: Review for Research and Institutional Review Boards. J Ultrasound Med. 2026 Mar;45(3):487-496. doi: 10.1002/jum.70085. Epub 2025 Oct 8.
PubMed 41059940Agrawal 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.
PubMed 32784534
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Photoacoustic Imaging of Hydrocephalus
- ClinicalTrials.gov ID
- NCT07784179
- Acronym / sponsor ID
- STUDY00027200
- Keywords
- Hydrocephalus, Photoacoustic Ultrasound Imaging, PAUS Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Michael McDowellUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAUS imaging | Experimental | Diagnostic Test: PAUS imagingPatients in this arm will undergo PAUS imaging before and after hydrocephalus treatment procedures and, if applicable, during cerebrospinal removal procedures at the bedside. |
Who may qualify
- Ages
- 0 days to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAUS imagingPAUS imaging will be conducted before and after hydrocephalus treatment procedures and, if applicable, during cerebrospinal removal procedures at the bedside. | Diagnostic test | PAUS imaging |
Primary outcome
PAUS Imaging Depth Prior to Hydrocephalus Treatment
Time frame: During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.
Quantitative measurement of PAUS imaging depth (mm), obtained prior to surgery or other hydrocephalus treatment.
PAUS Imaging Depth Following Hydrocephalus Treatment
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
Quantitative measurement of PAUS imaging depth (mm), obtained following surgery or other hydrocephalus treatment.
PAUS Spatial Resolution Prior to Hydrocephalus Treatment
Time frame: During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.
Quantitative measurement of PAUS spatial resolution (mm), obtained prior to surgery or other hydrocephalus treatment.
PAUS Spatial Resolution Following Hydrocephalus Treatment
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
Quantitative measurement of PAUS spatial resolution (mm), obtained following surgery or other hydrocephalus treatment.
PAUS Imaging Contrast Prior to Hydrocephalus Treatment
Time frame: During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.
Quantitative measurement of PAUS imaging contrast (dB), obtained prior to surgery or other hydrocephalus treatment.
PAUS Imaging Contrast Following Hydrocephalus Treatment
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
Quantitative measurement of PAUS imaging contrast (dB), obtained following surgery or other hydrocephalus treatment.
7 secondary outcomes
CSF Outflow Patency Prior to 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
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
Function of Cerebrospinal Fluid (CSF) Diversion Device
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
PAUS Assessment of Hydrocephalus Resolution
Time frame: During the post-treatment PAUS imaging session, occurring within 7 days after hydrocephalus treatment.
PAUS Imaging Depth During Bedside Procedure
Time frame: During the bedside procedure.
PAUS Spatial Resolution During Bedside Procedure
Time frame: During the bedside procedure.
PAUS Imaging Contrast During Bedside Procedure
Time frame: During the bedside procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 31293884Steinberg I, Huland DM, Vermesh O, Frostig HE, Tummers WS, Gambhir SS. Photoacoustic clinical imaging. Photoacoustics. 2019 Jun 8;14:77-98. doi: 10.1016/j.pacs.2019.05.001. eCollection 2019 Jun.
- Background: PubMed 22442475Wang LV, Hu S. Photoacoustic tomography: in vivo imaging from organelles to organs. Science. 2012 Mar 23;335(6075):1458-62. doi: 10.1126/science.1216210.
- Background: PubMed 29907740Lin L, Hu P, Shi J, Appleton CM, Maslov K, Li L, Zhang R, Wang LV. Single-breath-hold photoacoustic computed tomography of the breast. Nat Commun. 2018 Jun 15;9(1):2352. doi: 10.1038/s41467-018-04576-z.
- Background: PubMed 16823374Zhang HF, Maslov K, Stoica G, Wang LV. Functional photoacoustic microscopy for high-resolution and noninvasive in vivo imaging. Nat Biotechnol. 2006 Jul;24(7):848-51. doi: 10.1038/nbt1220. Epub 2006 Jun 25.
- Background: PubMed 31189720Galanzha EI, Menyaev YA, Yadem AC, Sarimollaoglu M, Juratli MA, Nedosekin DA, Foster SR, Jamshidi-Parsian A, Siegel ER, Makhoul I, Hutchins LF, Suen JY, Zharov VP. In vivo liquid biopsy using Cytophone platform for photoacoustic detection of circulating tumor cells in patients with melanoma. Sci Transl Med. 2019 Jun 12;11(496):eaat5857. doi: 10.1126/scitranslmed.aat5857.
- Background: PubMed 29514074Reber J, Willershauser M, Karlas A, Paul-Yuan K, Diot G, Franz D, Fromme T, Ovsepian SV, Beziere N, Dubikovskaya E, Karampinos DC, Holzapfel C, Hauner H, Klingenspor M, Ntziachristos V. Non-invasive Measurement of Brown Fat Metabolism Based on Optoacoustic Imaging of Hemoglobin Gradients. Cell Metab. 2018 Mar 6;27(3):689-701.e4. doi: 10.1016/j.cmet.2018.02.002.
- Background: PubMed 29675317Dasa MK, Markos C, Maria M, Petersen CR, Moselund PM, Bang O. High-pulse energy supercontinuum laser for high-resolution spectroscopic photoacoustic imaging of lipids in the 1650-1850 nm region. Biomed Opt Express. 2018 Mar 20;9(4):1762-1770. doi: 10.1364/BOE.9.001762. eCollection 2018 Apr 1.
- Background: PubMed 22734739Allen TJ, Hall A, Dhillon AP, Owen JS, Beard PC. Spectroscopic photoacoustic imaging of lipid-rich plaques in the human aorta in the 740 to 1400 nm wavelength range. J Biomed Opt. 2012 Jun;17(6):061209. doi: 10.1117/1.JBO.17.6.061209.
- Background: PubMed 20615021Xu Z, Li C, Wang LV. Photoacoustic tomography of water in phantoms and tissue. J Biomed Opt. 2010 May-Jun;15(3):036019. doi: 10.1117/1.3443793.
- Background: PubMed 31565515Yan Y, Gomez-Lopez N, Basij M, Shahvari AV, Vadillo-Ortega F, Hernandez-Andrade E, Hassan SS, Romero R, MehrMohammadi M. Photoacoustic imaging of the uterine cervix to assess collagen and water content changes in murine pregnancy. Biomed Opt Express. 2019 Aug 19;10(9):4643-4655. doi: 10.1364/BOE.10.004643. eCollection 2019 Sep 1.
- Background: PubMed 37289088Paulus LP, Buehler A, Wagner AL, Raming R, Jungert J, Simon D, Tascilar K, Schnell A, Rother U, Eckstein M, Lang W, Hoerning A, Schett G, Neurath MF, Waldner MJ, Trollmann R, Woelfle J, Bohndiek SE, Regensburger AP, Knieling F. Contrast-Enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Tract. Adv Sci (Weinh). 2023 Aug;10(23):e2302562. doi: 10.1002/advs.202302562. Epub 2023 Jun 8.
- Background: PubMed 37575972Manwar R, Kratkiewicz K, Mahmoodkalayeh S, Hariri A, Papadelis C, Hansen A, Pillers DM, Gelovani J, Avanaki K. Development and characterization of transfontanelle photoacoustic imaging system for detection of intracranial hemorrhages and measurement of brain oxygenation: Ex-vivo. Photoacoustics. 2023 Jul 27;32:100538. doi: 10.1016/j.pacs.2023.100538. eCollection 2023 Aug.
- Individual participant dataSharing planned: No. Patient data will be coded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael M McDowell, MD principal investigator
Milton S. Hershey Medical Center
Sri-Rajasekhar Kothapalli, PhD principal investigator
Penn State University
Questions about this trial
What is this clinical trial studying?
A study testing PAUS imaging in people with Hydrocephalus in Infants and Hydrocephalus in Children, run by Michael McDowell.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael M McDowell, MD (717-531-7123, mmcdowell1@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAUS Imaging Depth Prior to Hydrocephalus Treatment (time frame: During the pre-treatment PAUS imaging session, occurring within 7 days prior to hydrocephalus treatment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07784179, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.