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

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Diagnostic Test: serial functional magnetic resonance imaging (MRI)

• Registration Number: NCT03458897
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-05-03
• Primary Completion: 2020-08-16
• Study Completion: 2020-09-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI arm	serial functional magnetic resonance imaging (MRI)	Subjects with sickle cell disease undergoing bone marrow transplantation will undergo serial functional MRI (up to 4 scans).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States