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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for studying hydrocephalus, a condition where fluid accumulates in the brain. Researchers use a special dye, indocyanine green (ICG), to observe fluid movement and detect any inflammation. Advanced imaging techniques will track the dye, providing data on fluid flow and inflammation. The trial seeks premature babies in the NICU with hydrocephalus who have a small device to help drain the fluid. This study aims to enhance understanding and treatment options for hydrocephalus in these infants. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these imaging techniques are safe for assessing hydrocephalus?

Research has shown that using small amounts of indocyanine green (ICG) in clinical imaging is generally safe. Studies found that injecting ICG in tiny doses into the brain's fluid spaces does not cause harm. The amount of ICG in the spinal fluid of patients ranged from 0.17 to 7.93 micromolars, which is considered safe. Importantly, these studies reported no negative effects, suggesting that this use of ICG is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the imaging techniques being studied for hydrocephalus because they involve the use of Indocyanine Green (ICG) for enhanced imaging. Unlike standard treatments that primarily focus on draining excess cerebrospinal fluid, this approach uses a novel method called Near-Infrared Fluorescence (NIRF) imaging with ICG to visualize the brain's ventricles more clearly. This can potentially lead to more precise diagnostic and treatment planning, improving outcomes for patients with hydrocephalus.

What evidence suggests that these imaging techniques are effective for hydrocephalus?

Research has shown that small amounts of a dye called indocyanine green (ICG) can help doctors understand fluid movement in and out of the brain. In this trial, participants will receive ventricular microdosing of ICG to track cerebrospinal fluid (CSF) flow. Special imaging techniques, such as fluorescent Cap-based Transcranial Optical Tomography (fCTOT) and Near-InfraRed Fluorescent (NIRF) imaging, provide a clear view of CSF movement. This is crucial for conditions like hydrocephalus, where fluid accumulates in the brain. Past research has successfully used ICG to highlight important blood vessels during brain surgeries, suggesting its effectiveness for this new application. ^{1 3 4 6 7}

Who Is on the Research Team?

Manish Shah, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40029024/

Safety of Indocyanine Green Microdosing for Clinical Imaging ... Conclusions: With intraventricular microdosing of 100 µg ICG, maximal ICG concentrations in neonatal CSF range from 1.3 to 6 5 µM. CNS cell culture, rat safety ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06994949

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic ... The purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (ICG) in order to assess ...

3. withpower.com withpower.com/trial/imaging-techniques-for-hydrocephalus-4af19

Imaging Techniques for Hydrocephalus 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 ( ...

4. researchgate.net researchgate.net/publication/389520202_Safety_of_Indocyanine_Green_Microdosing_for_Clinical_Imaging_of_CSF_Ventricular_Dynamics_and_Extracranial_Outflow

Safety of Indocyanine Green Microdosing for Clinical ... The results confirm the ability to use trace doses of ICG to monitor ventricular CSF dynamics and extracranial outflow in NHP.

5. fortunejournals.com fortunejournals.com/articles/a-surgical-first-application-of-indocyanine-green-fluorescence-imaging-for-endoscopic-third-ventriculostomy-in-an-infant.html

Application of Indocyanine Green Fluorescence Imaging ... To our knowledge we report for the first time the application of indocyanine green fluorescence imaging to visualize the basilar artery during an ETV to prevent ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06994949?draw=2&rank=1

Study Details | NCT06994949 | Assessing CSF Flow Dynamics ... The purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (ICG) in order to assess cerebrospinal ...

7. consensus.app consensus.app/papers/details/f99c45c1c9f75bddb6dc595bc9c89414/

Safety of Indocyanine Green Microdosing for Clinical ... Key takeaway: 'Indocyanine green microdosing in cerebrospinal fluid is safe and feasible for clinical imaging of CSF ventricular dynamics ...