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

Not Applicable

Withdrawn

• Conditions: Leukemia
• Interventions: Device: MagProbe (TM)

• Registration Number: NCT01411904
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MagProbe (TM)	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

Primary Outcome Measures

Name	Time	Method
Lymphoblast percent	1 day	Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample

Secondary Outcome Measures

Name	Time	Method
SQUID magnetometry	1 day	Magnetic Signal from the nanoparticles bound to the leukemia cells

Trial Locations

Locations (1)

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States