Study of the Detection of Lymphoblasts by a Novel Magnetic Needle and Nanoparticles in Patients With Leukemia

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01411904
First received: April 18, 2011
Last updated: August 5, 2011
Last verified: April 2011
  Purpose

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 Phase
Leukemia
Device: MagProbe (TM)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Lymphoblast percent [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample


Secondary Outcome Measures:
  • SQUID magnetometry [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Magnetic Signal from the nanoparticles bound to the leukemia cells


Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic Needle

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

Leukemia patients

  • Magnetic needle
  • Diagnosed or suspected leukemia

Non-leukemia patients

  • Magnetic needle
  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411904

Locations
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
  More Information

No publications provided

Responsible Party: Richard S. Larson, University of New Mexico School of Medicine
ClinicalTrials.gov Identifier: NCT01411904     History of Changes
Other Study ID Numbers: 06-049, 5R44CA105742-05
Study First Received: April 18, 2011
Last Updated: August 5, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of New Mexico:
Leukemia
magnetic needle
magnetic nanoparticles
CD34

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014