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临床试验/NCT01411904
NCT01411904撤回不适用

A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia

University of New Mexico2 个研究点 分布在 1 个国家开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Lymphoblast percent

研究概览

简要总结

The purpose of this study is to determine if the magnetic needle, in combination with magnetic nanoparticles can accurately identify minimal residual disease in leukemia patients.

详细描述

The ability to reliably detect Minimal Residual Disease (MRD) in leukemia patients allows oncologists to predict patient outcome and to monitor the efficacy of therapy which is critical to improving care. MRD can be used to identify high risk patients who cannot be identified by conventional high risk features, a presence of < 0.1% MRD has been shown to be one of the best predictors of 5-year remission, with 70% of patients with ≥ 0.1% relapsing. In addition to providing predictions of relapse, MRD has been shown to provide a sensitive measure of early treatment response, an independent predictor of good outcome. While the presence of MRD is indicative of patient outcome, the detection of the presence of MRD provides an opportunity to modify treatment and potentially increase survival. Studies are currently underway to use MRD detection in modifying chemotherapeutic treatment and timing of stem cell transplant in leukemia patients. Development of a low cost and easily accessible MRD detector has the potential to expand the number of patients for which MRD testing is available. Expansion of the patient population is a necessary step to large scale testing of MRD detection as both a predictive factor of patient outcome and as a potential modifier of patient treatment. It is expected that increased MRD testing would lead to improved prediction of patient outcomes and increased sensitivity of testing of treatment response. MRD testing in the general patient population could be used to test treatment response and allow oncologists to modify treatment regiments leading to reduced patient mortality and improved medical outcomes.

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

性别
All
接受健康志愿者

入选标准

  • Suspected diagnosis of Leukemia
  • Requiring bone marrow biopsy for standard care

排除标准

  • unable to consent for entrance into the study
  • Group: Non-leukemia Patients
  • Inclusion Criteria:
  • Requiring bone marrow biopsy for standard care
  • Exclusion Criteria:
  • unable to consent for entrance into the study
  • Leukemia diagnosis

结局指标

主要结局

Lymphoblast percent

时间窗: 1 day

Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample

次要结局

  • SQUID magnetometry(1 day)

研究者

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

Richard Larson

Executive Vice Chancellor Vice Chancellor for Research

University of New Mexico

研究点 (2)

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