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

NCT03458897 | Completed

• 1 other identifier: HUM00132776
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

bone marrow cellularity; bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant

  Feasibility will be measured by the number of subjects who undergo at least 2 of 4 scheduled functional MRI's

  110 days post transplant

Secondary Outcomes (3)

• MRI and hemoglobin S.

  1 year post transplant

• MRI and neutrophil engraftment

  1 year post transplant

• MRI and chimerism

  1 year post transplant

Study Arms (1)

MRI arm

EXPERIMENTAL

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

Diagnostic Test: serial functional magnetic resonance imaging (MRI)

Interventions

serial functional magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

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

MRI arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ghada Abusin, MBBS MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: May 3, 2018
• Primary Completion: August 16, 2020
• Study Completion: September 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)