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

NCT ID: NCT01411904

Last Updated: 2015-12-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Leukemia

Keywords

Leukemia; magnetic needle; magnetic nanoparticles; CD34

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MagProbe (TM)

Intervention Type: DEVICE

CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy

Interventions

MagProbe (TM)

CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy

Intervention Type: DEVICE

Other Intervention Names

Magnetic Needle

Eligibility Criteria

Inclusion Criteria

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

• Requiring bone marrow biopsy for standard care

Exclusion Criteria

• unable to consent for entrance into the study

Group: Non-leukemia Patients

• unable to consent for entrance into the study
• Leukemia diagnosis

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Richard Larson

Executive Vice Chancellor Vice Chancellor for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

5R44CA105742-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-049

Identifier Type: -

Identifier Source: org_study_id