Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01411904
Status:
WITHDRAWN
Last Update Posted:
2015-12-11
First Post:
2011-04-18
Brief Title:
A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 MRD has been shown to be one of the best predictors of 5-year remission with 70 of patients with 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44CA105742-05 | NIH | None | httpsreporternihgovquickSearch5R44CA105742-05 |