Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03458897

Enrollment

Registered

2018-03-08

Start date

2018-05-03

Completion date

2020-09-01

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

bone marrow cellularity, bone marrow transplant

Brief summary

The primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease.

Interventions

DIAGNOSTIC_TESTserial functional magnetic resonance imaging (MRI)

All subjects with sickle cell disease undergoing bone marrow transplantation will undergo up to 4 functional MRI scans.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 5 years. * Diagnosis of SCD (\[Hemoglobin SS (Hb-SS), Hemoglobin SC (Hb-SC) or Hemoglobin S-Beta thalassemia (Hb-Sβ) genotype\]. * Patient is a candidate for an allogeneic HCT. * Subject or guardians have given informed consent.

Exclusion criteria

* The need for general anesthesia for MRI. * Subjects with implanted magnetic devices (e.g. pacemakers) that may malfunction or move in the strong magnetic field. * A subject who is pregnant. * Previous HCT.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant	110 days post transplant	Feasibility will be measured by the number of subjects who undergo at least 2 of 4 scheduled functional MRI's

Secondary

Measure	Time frame	Description
MRI and hemoglobin S.	1 year post transplant	Correlation between functional MRI result and hemoglobin S level.
MRI and neutrophil engraftment	1 year post transplant	Correlation between functional MRI result and time to neutrophil engraftment
MRI and chimerism	1 year post transplant	Correlation between functional MRI result and time to donor/ recipient chimerism

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026