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

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ClinicalTrials.gov Identifier: NCT01411904
Recruitment Status : Withdrawn (The NPs that we have been buying from a vendor show lot to lot variation.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.)
First Posted : August 8, 2011
Last Update Posted : December 11, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Richard Larson, University of New Mexico

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.

Condition or disease Intervention/treatment
Leukemia Device: MagProbe (TM)

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia
Study Start Date : August 2010
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Leukemia
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Responsible Party: Richard Larson, Executive Vice Chancellor Vice Chancellor for Research, University of New Mexico
ClinicalTrials.gov Identifier: NCT01411904     History of Changes
Other Study ID Numbers: 06-049
5R44CA105742-05 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by Richard Larson, University of New Mexico:
magnetic needle
magnetic nanoparticles

Additional relevant MeSH terms:
Neoplasms by Histologic Type