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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01411904
• Other study ID #: 06-049
• Secondary ID: 5R44CA105742-05
• Status: Withdrawn
• Phase: N/A
• First received: April 18, 2011
• Last updated: December 10, 2015
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Leukemia

Intervention

Device:
• MagProbe (TM)
CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphoblast percent	Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample	1 day	No
Secondary	SQUID magnetometry	Magnetic Signal from the nanoparticles bound to the leukemia cells	1 day	No