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

November 11, 2020 updated by: Ghada Abusin, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI arm
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)
All subjects with sickle cell disease undergoing bone marrow transplantation will undergo up to 4 functional MRI scans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant
Time Frame: 110 days post 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI and hemoglobin S.
Time Frame: 1 year post transplant
Correlation between functional MRI result and hemoglobin S level.
1 year post transplant
MRI and neutrophil engraftment
Time Frame: 1 year post transplant
Correlation between functional MRI result and time to neutrophil engraftment
1 year post transplant
MRI and chimerism
Time Frame: 1 year post transplant
Correlation between functional MRI result and time to donor/ recipient chimerism
1 year post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Ghada Abusin, MBBS MS, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2018

Primary Completion (Actual)

August 16, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00132776

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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