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Study of Methodologies to Measure Blood Flow and Oxygenation in Adults With Sickle Cell Disease

2020年12月16日 更新者:Bioverativ Therapeutics Inc.

A Study of Methodologies to Measure Blood Flow and Oxygenation as Potential Biomarkers in Adults With Sickle Cell Disease

The purpose of the study is to determine whether imaging techniques, such as magnetic resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in different organ systems of participants with sickle cell disease (SCD). Differences in blood flow and oxygen levels detected by these techniques will be evaluated to determine their utility as biomarkers of clinical disease pathophysiology.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

38

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Detroit、Michigan、美国、48201
        • Research Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Participants with mild to severe VOC

描述

Key Inclusion Criteria:

  1. Have a diagnosis of SCD confirmed by hemoglobin analysis.
  2. Be in stable clinical condition, as determined by the Investigator.

    Subjects enrolled in Part B must also meet the following eligibility criterion at Screening:

  3. Receiving scheduled standard of care RBC exchange transfusion therapy, with ≥3 transfusions already received.
  4. Be deemed healthy, as determined by the Investigator, based on the physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements.

Key Exclusion Criteria:

  1. Inability to lie still for ≥5 minutes, claustrophobia sufficient to interfere with generating reliable MRI scans, body weight exceeding 320.0 lbs., or girth exceeding the magnet bore.
  2. Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) which would be a contraindication for MRI.
  3. Acute pain crisis requiring hospitalization, with a discharge ≤4 weeks prior to the first imaging visit, or when determined by the Investigator to not be at steady state.
  4. Recent (≤3 months) treatment with hydroxyurea therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
Part A
Cohort 1- Participants with severe SCD (4-10 VOC/year) Cohort 2- Participants with milder SCD (<4-10 VOC/year) Cohort 3- Healthy volunteers Part A and B can occur in parallel
Part B
Adults with SCD receiving chronic red blood cell exchange transfusion Part A and B can occur in parallel

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Blood flow in the brain of adults with severe SCD (4-10 vaso-occlusive crises [VOC]/ year) compared to healthy adults without SCD as assessed by MRI-ASL (arterial spin labeling)
大体时间:Up to day 18 post screening visit
Up to day 18 post screening visit

次要结果测量

结果测量
大体时间
Kidney blood flow rates as assessed by MRI-SWI (susceptibility-weighted imaging)
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Skeletal muscle blood flow rates as assessed by NIRS
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Skin blood flow rates as assessed by LSCI
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Retinal blood flow rates as assessed by OI
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Total oxygen levels in the brain as assessed by MRI-ASL
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Total oxygen levels in the kidney as assessed by MRI-SWI
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Total oxygen levels in the muscle as assessed by NIRS
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Total oxygen levels in the skin as assessed by LSCI
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit
Total oxygen levels in the retina as assessed by OI
大体时间:Up to day 21 post screening visit
Up to day 21 post screening visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Medical Director、Bioverativ Therapeutics Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年6月1日

初级完成 (实际的)

2016年10月1日

研究完成 (实际的)

2016年10月1日

研究注册日期

首次提交

2015年4月16日

首先提交符合 QC 标准的

2015年5月14日

首次发布 (估计)

2015年5月19日

研究记录更新

最后更新发布 (实际的)

2020年12月19日

上次提交的符合 QC 标准的更新

2020年12月16日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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