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临床试验/NCT03458897
NCT03458897已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant

时间窗: 110 days post transplant

Feasibility will be measured by the number of subjects who undergo at least 2 of 4 scheduled functional MRI's

次要结局

  • MRI and neutrophil engraftment(1 year post transplant)
  • MRI and hemoglobin S.(1 year post transplant)
  • MRI and chimerism(1 year post transplant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Abusin

Assistant Professor

University of Michigan

研究点 (2)

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