Imaging Techniques for Hydrocephalus

Overseen By Fred C Velasquez

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Eva Sevick

Disqualifiers: Allergy to iodine or ICG, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (ICG) in order to assess cerebrospinal fluid (CSF) ventricular dynamics and extracranial CSF outflow using fluorescent Cap-based Transcranial Optical Tomography (fCTOT) and Near-InfraRed Fluorescent (NIRF) imaging and to evaluate inflammation markers of the CSF and to correlate with CSF ventricular dynamics, extracranial outflow into the lymphatics, ventriculomegaly, and patient's clinical outcome in order to understand how inflammation may impact that status of extracranial outflow.

Research Team

Manish Shah, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for children with hemorrhagic hydrocephalus, a condition where bleeding in the brain leads to fluid buildup. Participants must be suitable for the imaging techniques used and able to follow study procedures. Specific inclusion and exclusion criteria are not listed but would typically involve age range, disease severity, and absence of conditions that could interfere with imaging or pose risks.

Inclusion Criteria

My child is scheduled for a CT scan 3-4 weeks after getting a reservoir.

My child was born premature, is in the NICU with PHH, and has had a ventricular reservoir placed.

Exclusion Criteria

My child does not have a device for draining fluid from the brain.

My child is allergic to iodine or ICG.

Parents who do not consent for procedure on their child

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ventricular microdosing of indocyanine green (ICG) to assess CSF dynamics and outflow

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurement of pro-inflammatory cytokines

2 weeks

Treatment Details

Interventions

• Ventricular Microdosing of Indocyanine Green (ICG)

Trial Overview The study tests a new way to see how cerebrospinal fluid (CSF) moves in the brain using a special dye called ICG. It's given in tiny amounts and tracked with two advanced imaging methods: fCTOT cap and NIRF planar imaging. Researchers will also check if inflammation affects CSF movement by looking at markers in the CSF.

Participant Groups

Group I: fCTOT and NIRF imaging with ICG Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Eva Sevick

Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+