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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Leukemia

Intervention / Treatment
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* Device: MagProbe (TM)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MagProbe (TM)<br>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)<br>* CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy<br>* Other names: Magnetic Needle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphoblast percent | Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SQUID magnetometry | Magnetic Signal from the nanoparticles bound to the leukemia cells | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, magnetic needle, magnetic nanoparticles, CD34