- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03458897
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
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
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).
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All subjects with sickle cell disease undergoing bone marrow transplantation will undergo up to 4 functional MRI scans.
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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
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Feasibility will be measured by the number of subjects who undergo at least 2 of 4 scheduled functional MRI's
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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
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Correlation between functional MRI result and time to neutrophil engraftment
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1 year post transplant
|
MRI and chimerism
Time Frame: 1 year post transplant
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Correlation between functional MRI result and time to donor/ recipient chimerism
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1 year post transplant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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