Skip to main content
OpenTrials
Completed

NCT Number: NCT03458897

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

serial functional magnetic resonance imaging (MRI)

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2018
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.