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

University of Michigan

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Diagnostic Test: serial functional magnetic resonance imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03458897

HUM00132776

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

MRI arm

Experimental group

Description:

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

Treatment:

Diagnostic Test: serial functional magnetic resonance imaging (MRI)