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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458897
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ghada Abusin, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Diagnostic Test: serial functional magnetic resonance imaging (MRI) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant
Actual Study Start Date : May 3, 2018
Actual Primary Completion Date : August 16, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. MRI and hemoglobin S. [ Time Frame: 1 year post transplant ]
    Correlation between functional MRI result and hemoglobin S level.

  2. MRI and neutrophil engraftment [ Time Frame: 1 year post transplant ]
    Correlation between functional MRI result and time to neutrophil engraftment

  3. MRI and chimerism [ Time Frame: 1 year post transplant ]
    Correlation between functional MRI result and time to donor/ recipient chimerism


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458897


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Ghada Abusin, MBBS MS University of Michigan
More Information
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Responsible Party: Ghada Abusin, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03458897    
Other Study ID Numbers: HUM00132776
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghada Abusin, University of Michigan:
bone marrow cellularity
bone marrow transplant
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn