Study Stopped
The NPs that we have been buying from a vendor show lot to lot variation. We are making our own NPs, need to characterize them before we enroll new patients.
A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2010
Typical duration for not_applicable leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 11, 2015
December 1, 2015
3.3 years
April 18, 2011
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lymphoblast percent
Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample
1 day
Secondary Outcomes (1)
SQUID magnetometry
1 day
Study Arms (1)
MagProbe (TM)
EXPERIMENTALPatients 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
Interventions
CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy
Eligibility Criteria
You may qualify if:
- Suspected diagnosis of Leukemia
- Requiring bone marrow biopsy for standard care
You may not qualify if:
- unable to consent for entrance into the study
- Group: Non-leukemia Patients
- Requiring bone marrow biopsy for standard care
- unable to consent for entrance into the study
- Leukemia diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of New Mexicolead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice Chancellor Vice Chancellor for Research
Study Record Dates
First Submitted
April 18, 2011
First Posted
August 8, 2011
Study Start
August 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 11, 2015
Record last verified: 2015-12