What is this study trying to find out about sickle cell disease?

This study is exploring how advanced imaging and optical techniques can monitor brain blood flow and oxygen use in children with sickle cell disease. Researchers want to find ways to detect when treatment is needed and measure how well treatments work for each patient. This research is supported by Boston Children's Hospital to improve monitoring methods in sickle cell disease.

Who may be eligible for this sickle cell disease clinical trial?

Children aged 8 to 18 years may be eligible, including healthy children and those with sickle cell disease with various treatment statuses. Both boys and girls can participate. Key factors include not having certain metal implants, not requiring sedation for MRI, and not being pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this sickle cell disease clinical trial?

Study-related care, including MRI scans and optical monitoring, is provided at no cost. However, personal travel or other expenses may not be covered. Participants can expect all study procedures to be covered but should plan for their own travel costs.

Actively Recruiting

Age: 8Years - 18Years

All Genders

ID04166526

A Pilot Study Using MRI and Optical Techniques to Monitor Brain Oxygen and Blood Flow in Children with Sickle Cell Disease Ages 8 to 18

Led by Boston Children's Hospital · Updated on 2025-12-12

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Sickle Cell Disease SCD affects oxygen transport and causes damage to blood vessels, especially impacting the brain. Researchers are evaluating new ways to monitor SCD and its treatments by measuring brain blood flow, oxygen use, and blood vessel function using advanced MRI and optical techniques. This study aims to find biomarkers to guide when treatment is needed and measure how well treatments work for each patient, helping to personalize care and support future SCD therapies. Participants are grouped based on their SCD status and treatments healthy children without SCD, children with SCD not receiving treatment, children who have had gene therapy, and children on chronic transfusions. All participants undergo an MRI scan lasting about an hour combined with simultaneous optical monitoring. Those on chronic transfusions have additional MRI scans and optical tests before, during, and after transfusions to track changes. During the study, participants will have one or two MRI sessions with simultaneous optical measurements to assess brain oxygen transport and blood vessel response. Researchers will collect data on how these measurements change with treatment and compare groups with different SCD statuses. The main outcome is the accuracy of the optical device FDNIRS-DCS in measuring brain blood oxygen levels over six months. The study runs until August 2027 and involves children aged 8 to 18 years.

CONDITIONS

Brief Title

A Pilot Study on Neuroimaging in SCD: Part of The Boston Consortium to Cure Sickle Cell Disease

Who Can Participate

Age: 8Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Children aged 8 to 18 years without sickle cell disease (healthy controls)
Children aged 8 to 18 years with sickle cell disease who have not had gene therapy or bone marrow transplant
Children aged 8 to 18 years with sickle cell disease not receiving chronic transfusions and no blood transfusion in past 3 months
Children aged 8 to 18 years with sickle cell disease who have had gene therapy at least one month before enrollment
Children aged 8 to 18 years with sickle cell disease who receive chronic transfusions

You will not qualify if you...

Having electrical implants such as cardiac pacemakers or perfusion pumps
Having ferromagnetic implants like aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
Wearing ferromagnetic objects such as jewelry or metal clips
Women of childbearing age who are planning pregnancy, breastfeeding, or suspect they may be pregnant
Pre-existing medical conditions with a likelihood of seizures or claustrophobic reactions
Having greater than normal potential for cardiac arrest
Requiring sedation for MRI

Research Team

Ellen Grant, MD

Katherine Eident, BS

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