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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

April 18, 2011
August 5, 2011
August 2010
August 2012   (final data collection date for primary outcome measure)
Lymphoblast percent [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample
Same as current
Complete list of historical versions of study NCT01411904 on ClinicalTrials.gov Archive Site
SQUID magnetometry [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Magnetic Signal from the nanoparticles bound to the leukemia cells
Same as current
Not Provided
Not Provided
 
Study of the Detection of Lymphoblasts by a Novel Magnetic Needle and Nanoparticles in Patients With Leukemia
Not Provided

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Leukemia
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
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
Intervention: Device: MagProbe (TM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
January 2013
August 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01411904
06-049, 5R44CA105742-05
No
Richard S. Larson, University of New Mexico School of Medicine
University of New Mexico
National Cancer Institute (NCI)
Not Provided
University of New Mexico
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP