Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT01411904
Status:
WITHDRAWN
Last Update Posted:
2015-12-11
First Post:
2011-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': '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 We are making our own NPs, need to characterize them before we enroll new patients.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2011-04-18', 'studyFirstSubmitQcDate': '2011-08-05', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymphoblast percent', 'timeFrame': '1 day', 'description': 'Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample'}], 'secondaryOutcomes': [{'measure': 'SQUID magnetometry', 'timeFrame': '1 day', 'description': 'Magnetic Signal from the nanoparticles bound to the leukemia cells'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leukemia', 'magnetic needle', 'magnetic nanoparticles', 'CD34'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Group: Leukemia Patients\n\nInclusion Criteria:\n\n* Suspected diagnosis of Leukemia\n* Requiring bone marrow biopsy for standard care\n\nExclusion Criteria:\n\n* unable to consent for entrance into the study\n\nGroup: Non-leukemia Patients\n\nInclusion Criteria:\n\n* Requiring bone marrow biopsy for standard care\n\nExclusion Criteria:\n\n* unable to consent for entrance into the study\n* Leukemia diagnosis'}, 'identificationModule': {'nctId': 'NCT01411904', 'briefTitle': 'A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia', 'orgStudyIdInfo': {'id': '06-049'}, 'secondaryIdInfos': [{'id': '5R44CA105742-05', 'link': 'https://reporter.nih.gov/quickSearch/5R44CA105742-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MagProbe (TM)', 'description': 'Patients whose bone marrow aspirates are exposed to the MagProbe and CD34 nanoparticles.\n\nLeukemia patients\n\n* MagProbe (TM)\n* Diagnosed or suspected leukemia\n\nNon-leukemia patients\n\n* MagProbe (TM)\n* Requiring bone marrow biopsy', 'interventionNames': ['Device: MagProbe (TM)']}], 'interventions': [{'name': 'MagProbe (TM)', 'type': 'DEVICE', 'otherNames': ['Magnetic Needle'], 'description': 'CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy', 'armGroupLabels': ['MagProbe (TM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Vice Chancellor Vice Chancellor for Research', 'investigatorFullName': 'Richard Larson', 'investigatorAffiliation': 'University of New Mexico'}}}}