Recruiting

Imaging Biomarkers

Sponsor:

Washington University School of Medicine

Code:

NCT07776444

Conditions

Sickle Cell Disease

Cerebral Stroke

Eligibility Criteria

Sex: All

Age: 6 - 70

Healthy Volunteers: Accepted

Interventions

Carbon Dioxide

Study Details

Brief summary:

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.

Conditions

Sickle Cell Disease

Cerebral Stroke

Study ID

NCT07776444

Start date

Oct 1, 2025

Status verified date

Aug, 2026

Completion date

Sep 30, 2032

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Healthy Controls

active comparator: Sickle Cell Anemia Participants

Interventions

Carbon Dioxide

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 outcome measure

  • HDDOT-Based Cerebrovascular Reactivity [ Time Frame: ~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging. ]

Central Contacts and Locations

Central contacts

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Kristin Guilliams, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • cerebrovascular reactivity
  • magnetic resonance imaging
  • High density diffuse optical tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-20.