Actively Recruiting
A Pilot Study on Neuroimaging in Sickle Cell Disease as Part of The Boston Consortium to Cure Sickle Cell Disease
Led by Boston Children's Hospital · Updated on 2025-12-12
8
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week for MRI scans
Participants undergo MRI scans lasting approximately one hour, with simultaneous FDNIRS-DCS monitoring to assess brain blood oxygenation. Group 4 participants have two MRI scans scheduled around their transfusion, with additional FDNIRS-DCS measurements before, during, and after their transfusion.
1 visit for Groups 1-3; 2 visits for Group 4 with additional monitoring during transfusion
Duration - 6 months
Participants are observed over 6 months to assess the accuracy of FDNIRS-DCS in measuring brain blood oxygenation.
Visits as needed for observational follow-up
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
E
Ellen Grant, MD
K
Katherine Eident, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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