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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458897
• Other study ID #: HUM00132776
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 1, 2020
• Est. primary completion date: August 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Age = 5 years.

• Diagnosis of SCD ([Hemoglobin SS (Hb-SS), Hemoglobin SC (Hb-SC) or Hemoglobin S-Beta thalassemia (Hb-Sß) 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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MRI and hemoglobin S.	Correlation between functional MRI result and hemoglobin S level.	1 year post transplant
Secondary	MRI and neutrophil engraftment	Correlation between functional MRI result and time to neutrophil engraftment	1 year post transplant
Secondary	MRI and chimerism	Correlation between functional MRI result and time to donor/ recipient chimerism	1 year post transplant