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NCT04166526 · ClinicalTrials.gov registry record
A Pilot Study on Neuroimaging in SCD: Part of The Boston Consortium to Cure Sickle Cell Disease
A clinical trial of Sickle Cell Disease, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 8
- Enrollment target
- 1
- Study location
NCT04166526: Recruiting study of Sickle Cell Disease, sponsored by Boston Children's Hospital.
NCT04166526 is a study of Sickle Cell Disease that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 8 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04166526, a study of Sickle Cell Disease, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Sickle Cell Disease (SCD) impairs oxygen transport to tissue and causes endothelial injury. Thus, therapeutic interventions aim to improve both, but there is an unmet need for biomarkers to determine when intervention is necessary and evaluate the effectiveness of the chosen intervention in individual patients. This study proposes to monitor SCD and its treatment through their impact on cerebral hemodynamics, as the brain is one of the most vulnerable and consequential targets of the disease. Specifically, this study will optimize quantitative magnetic resonance imaging (MRI) and advanced optical spectroscopy techniques such as frequency-domain near-infrared and diffuse correlation spectroscopies (FDNIRS-DCS) to monitor 1) cerebral oxygen transport with measures of cerebral blood flow (CBF), cerebral oxygen extraction fraction (OEF) and cerebral metabolic rate of oxygen consumption (CMRO2) and 2) endothelial function with cerebrovascular reactivity (CVR). Additionally, this study aims to monitor baseline cerebral oxygen transport and CVR, as well as changes that occur with treatment (transfusion or genetic therapy to induce fetal hemoglobin) and assess hemoglobinopathy patients with known genotypes and phenotypes. The ultimate goal is to demonstrate the potential of this monitoring approach to select individual SCD subjects for interventions and evaluate individual responses to treatment. Success will help justify inclusion of these modalities in ongoing and future clinical trials of novel SCD therapies.
Primary Outcome
Blood oxygenation of the brain will be measured using FDNIRS-DCS techniques and then compared with data from a simultaneous MRI scan.
Conditions Studied
Interventions
- DEVICE MRI
- DEVICE FDNIRS-DCS
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-10-25 |
| Est. Completion | 2027-08-01 |
What NCT04166526 shows while recruiting
NCT04166526 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which MRI is the first listed.
NCT04166526 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04166526 about?
NCT04166526 is a clinical study titled "A Pilot Study on Neuroimaging in SCD: Part of The Boston Consortium to Cure Sickle Cell Disease". Sickle Cell Disease (SCD) impairs oxygen transport to tissue and causes endothelial injury. Thus, therapeutic interventions aim to improve both, but there is an unmet need for biomarkers to determine when intervention is necessary and evaluate the effectiveness of the chosen intervention in individu...
What is the current status of trial NCT04166526?
This trial is currently recruiting. The enrollment target is 8 participants. The study started on 2019-10-25. Estimated completion is 2027-08-01.
What conditions does trial NCT04166526 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04166526?
The interventions under investigation include: MRI (DEVICE), FDNIRS-DCS (DEVICE).
Who is sponsoring clinical trial NCT04166526?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04166526 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04166526's enrollment target sits among peer trials
8 201st of 213 higher than 13 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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