Clinical trial Recruiting at 1 site Interventional Ages 6 to 70

Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients

Official title: Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography

Run by Washington University School of Medicine · NCT07776444 · Data updated 2026-11-12

This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.

Quick facts

Study typeInterventional
Ages6 Years to 70 Years
SexAll
Enrollment120 (estimated)
SponsorWashington University School of Medicine
Academic / other
Locations1 site (St Louis, Missouri)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedSeptember 30, 2030
Study endsSeptember 30, 2032
Registry record updatedAugust 20, 2026
Trial IDNCT07776444 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children and adults aged 6 to 70 who can undergo MRI and DOT monitoring, including those with various sickle cell genotypes.

Probably not a fit

Individuals unable to participate in MRI or DOT monitoring or with contraindications to MRI or the carbon dioxide challenge may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses HD-DOT alongside MRI-based measures to examine cerebrovascular reactivity and oxygen extraction in participants with and without altered cerebral oxygen delivery. Oxygen extraction fraction will be measured with MRI, while CVR will be assessed using a controlled carbon dioxide challenge delivered safely with the RespirACT device. The goal is to identify imaging biomarkers of brain tissue under metabolic stress and relate these biomarkers to clinical and radiologic outcomes. By applying HD-DOT, the study aims to characterize regional OEF and CVR trajectories over time and across participants. The trial is conducted at Washington University in St. Louis with no listed collaborators.

Why it matters

Potential benefit: If successful, the study could improve understanding of brain tissue stress in sickle cell disease and help tailor imaging-based risk assessments for stroke.

How similar studies have gone: Previous work has shown the value of MRI-based biomarkers for cerebrovascular health; the HD-DOT approach for simultaneous OEF and CVR measurement is exploratory in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Washington University in St. Louis
    St Louis, Missouri, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.