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Clinical Trials/NCT01411904
NCT01411904WithdrawnNot Applicable

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

University of New Mexico2 sites in 1 countryStarted: August 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
Lymphoblast percent

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Lymphoblast percent

Time Frame: 1 day

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

Secondary Outcomes

  • SQUID magnetometry(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Richard Larson

Executive Vice Chancellor Vice Chancellor for Research

University of New Mexico

Study Sites (2)

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