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

This study has been withdrawn prior to enrollment.
(The NPs that we have been buying from a vendor show lot to lot variation. We are making our own NPs, need to characterize them before we enroll new patients.)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Richard Larson, University of New Mexico Identifier:
First received: April 18, 2011
Last updated: December 10, 2015
Last verified: December 2015
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.

Condition Intervention
Device: MagProbe (TM)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia

Resource links provided by NLM:

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Lymphoblast percent [ Time Frame: 1 day ]
    Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample

Secondary Outcome Measures:
  • SQUID magnetometry [ Time Frame: 1 day ]
    Magnetic Signal from the nanoparticles bound to the leukemia cells

Enrollment: 0
Study Start Date: August 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MagProbe (TM)

Patients whose bone marrow aspirates are exposed to the MagProbe and CD34 nanoparticles.

Leukemia patients

  • MagProbe (TM)
  • Diagnosed or suspected leukemia

Non-leukemia patients

  • MagProbe (TM)
  • Requiring bone marrow biopsy
Device: MagProbe (TM)
CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy
Other Name: Magnetic Needle

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Group: Leukemia Patients

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01411904

United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
National Cancer Institute (NCI)
  More Information

Responsible Party: Richard Larson, Executive Vice Chancellor Vice Chancellor for Research, University of New Mexico Identifier: NCT01411904     History of Changes
Other Study ID Numbers: 06-049
5R44CA105742-05 ( US NIH Grant/Contract Award Number )
Study First Received: April 18, 2011
Last Updated: December 10, 2015

Keywords provided by University of New Mexico:
magnetic needle
magnetic nanoparticles

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms processed this record on May 22, 2017