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

Primary Purpose

Sickle Cell Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

serial functional magnetic resonance imaging (MRI)

About this trial

This is an interventional diagnostic trial for Sickle Cell Disease focused on measuring bone marrow cellularity, bone marrow transplant

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MRI and hemoglobin S.

Correlation between functional MRI result and hemoglobin S level.

MRI and neutrophil engraftment

Correlation between functional MRI result and time to neutrophil engraftment

MRI and chimerism

Correlation between functional MRI result and time to donor/ recipient chimerism

Full Information

NCT ID

NCT03458897

First Posted

March 2, 2018

Last Updated

November 11, 2020

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03458897

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

May 3, 2018 (Actual)

Primary Completion Date

August 16, 2020 (Actual)

Study Completion Date

September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

Keywords

bone marrow cellularity, bone marrow transplant

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MRI arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

serial functional magnetic resonance imaging (MRI)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

110 days post transplant

Secondary Outcome Measure Information:

Title

MRI and hemoglobin S.

Description

Correlation between functional MRI result and hemoglobin S level.

Time Frame

1 year post transplant

Title

MRI and neutrophil engraftment

Description

Correlation between functional MRI result and time to neutrophil engraftment

Time Frame

1 year post transplant

Title

MRI and chimerism

Description

Correlation between functional MRI result and time to donor/ recipient chimerism

Time Frame

1 year post transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ghada Abusin, MBBS MS

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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