RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-10-25
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04166526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children ages 8-18 without SCD
  2. * SCD patients ages 8-18 who:
  3. * have not undergone gene therapy or a bone marrow transplant
  4. * are not receiving chronic transfusions
  5. * have not received a blood transfusion in the past 3 months
  6. * SCD patients ages 8-18 who have had gene therapy at least one month prior to enrollment
  7. * SCD patients ages 8-18 who receive chronic transfusions
  1. * Electrical implants such as cardiac pacemakers or perfusion pumps;
  2. * Ferromagnetic implants such as aneurysm clips, surgical clips, prosthesis, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants;
  3. * Ferromagnetic objects such as jewelry or metal clips;
  4. * Women of childbearing age who are seeking to become pregnant, who are breastfeeding, or who suspect they may be pregnant;
  5. * Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions;
  6. * Any greater than normal potential for cardiac arrest;
  7. * Subjects requiring sedation for MRI

Contacts and Locations

Study Contact

Ellen Grant, MD
CONTACT
857-218-5111
Ellen.Grant@childrens.harvard.edu
Katherine Eident, BS
CONTACT
617-355-2184
katherine.eident@childrens.harvard.edu

Principal Investigator

Ellen Grant, MD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Ellen Grant, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-25
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2019-10-25
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • Sickle Cell
  • MRI
  • Near Infrared Spectroscopy (NIRS)

Additional Relevant MeSH Terms

  • Sickle Cell Disease