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NCT Number: NCT07776444

Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography

The purpose of the study protocol is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure oxygen extraction fraction (OEF) and cerebrovascular reactivity (CVR) in participants with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to deliver carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time. We will also use a high density diffuse optical tomography (HD-DOT) cap to assess the measurement of OEF and CVR. This study will investigate both regional OEF and CVR simultaneously to understand each marker's unique developmental trajectory and contribution to stroke risk in children. This work will expand insights into mechanisms of stroke in children and assess the feasibility of the HD-DOT cap for obtaining these insights by comparing a cohort of optical CVR and a cohort of MRI CVR.

In addition to the MRI and/or HD-DOT cap with RespirAct, participants may also have their vitals measured, complete cognitive testing, and complete a blood draw with a study visit. Participants may be followed for up to three years and may complete both an MRI scan and an HD-DOT scan within 1 week-12 months of each other. Participants may be invited back to repeat MRI and/or HD-DOT scans 1-2 times over the next three years.

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Key information

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Adam Eggebrecht

PRINCIPAL_INVESTIGATOR

Kristin Guilliams, MD

CONTACT

[email protected]

3144546120

Kristin Guilliams, MD

PRINCIPAL_INVESTIGATOR

About this study

The purpose of the study protocol is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure OEF and CVR in participants with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to deliver carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time. We will also use an HD-DOT cap to assess the measurement of OEF and CVR.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 6-70 Years Old
  • Able to participate in MRI scan without sedation
  • May or may not have HbSS or beta thalassemia null genotypes of sickle cell anemia

Exclusion criteria

  • Significant craniofacial malformation or technical contraindications to DOT monitoring (for HDDOT imaging)
  • Metal in/on the body that is contraindicated for MRI safety (for MRI imaging)

Treatment and study plan

Carbon dioxide

Other

Participants inhale carbon dioxide, delivered by computer-controlled delivery system, to target specific levels of carbon dioxide while in magnetic resonance imaging scan and/or during HDDOT imaging to measure cerebrovascular reactivity.

Primary outcomes

  1. HDDOT-Based Cerebrovascular Reactivity

    Time frame: ~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging.

    Changes in relative concentration of deoxyhemoglobin with fluctuations of carbon dioxide as compared to gold standard measurement of MRI-based cerebrovascular reactivity.

Secondary outcomes

  1. Cerebral Oxygen Metabolism

    Time frame: From administration of carbon dioxide to end of inhalation of carbon dioxide -- 60 minutes during MRI and/or HDDOT imaging.

    MRI-based cerebral based blood flow oxygen extraction fraction will be combined with laboratory data estimating arterial oxygen content to calculate cerebral oxygen metabolism.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Guilliams, MD

CONTACT

[email protected]

3144545436

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: HDDOT CVR

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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