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

NCT ID: NCT03458897

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2020-09-01

Brief Summary

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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

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Conditions

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Sickle Cell Disease

Keywords

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bone marrow cellularity bone marrow transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI arm

Subjects with sickle cell disease undergoing bone marrow transplantation will undergo serial functional MRI (up to 4 scans).

Group Type EXPERIMENTAL

serial functional magnetic resonance imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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serial functional magnetic resonance imaging (MRI)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Ghada Abusin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghada Abusin, MBBS MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00132776

Identifier Type: -

Identifier Source: org_study_id