Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT02610920
Status:
WITHDRAWN
Last Update Posted:
2019-03-26
First Post:
2015-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel Lymph Node Identification in the Axilla of Women With Breast Cancer Using Ultrasound and Iron Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to enroll subjects', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2015-11-15', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of core needle biopsy of sentinel lymph node', 'timeFrame': 'At time of surgery, about 7 days after initial core needle biopsy', 'description': 'The participants will undergo an outpatient iron tracer-guided ultrasound and axillary lymph node core needle biopsy at "day zero" (purposely done no more than 7 days prior to scheduled breast surgery). The investigators would like to see if this biopsied node was in fact the sentinel lymph node. This will be determined by all of the patients also undergoing their previously scheduled intraoperative sentinel lymph node biopsy (standard of care) at about day 7. The success rate will measure what percentage of the preoperative lymph nodes biopsied with this novel technique were truly sentinel lymph node(s).'}], 'secondaryOutcomes': [{'measure': 'Concordance rate of core needle biopsy pathology to sentinel lymph node biopsy pathology', 'timeFrame': 'At time of pathology reports, about 17 days after initial core needle biopsy', 'description': 'The investigators will measure the concordance rate of the novel iron-tracer guided lymph node core needle biopsy pathology results (determining if cancer cells are present or not) compared to the operative sentinel lymph node pathology results. The novel technique core needle biopsy will occur on day zero. The surgery with concurrent sentinel lymph node biopsy will be on or before day 7, and both pathology reports should be back by day 17.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasm', 'Carcinoma, Ductal, Breast', 'Carcinoma, Intraductal, Noninfiltrating']}, 'referencesModule': {'references': [{'pmid': '24566860', 'type': 'BACKGROUND', 'citation': 'Kusminsky RE, Witsberger T, Todd Kuenstner J, Willis Trammell S, Schlarb CA, Maxwell D, Richmond BK, Boland JP. Identification of the sentinel node by ultrasonography in patients with breast cancer. Ann Surg Oncol. 2014 Jun;21(6):1969-74. doi: 10.1245/s10434-014-3570-4. Epub 2014 Feb 25.'}, {'pmid': '22302256', 'type': 'BACKGROUND', 'citation': 'Bailie GR. Comparison of rates of reported adverse events associated with i.v. iron products in the United States. Am J Health Syst Pharm. 2012 Feb 15;69(4):310-20. doi: 10.2146/ajhp110262.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. All participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible lymph nodes visible, allowing them to be sampled in an outpatient setting.', 'detailedDescription': 'Lymph nodes are small collections of tissue all over the body that drain bodily fluid. These axillary lymph nodes are important in evaluating breast cancer since, if they are positive, it suggests that the cancer cells have spread outside of the breast. The current standard of care is for most breast cancer patients undergoing surgery to have a sentinel lymph node biopsy which is a procedure to take a sample of the lymph nodes in the armpit (also called the axilla) during their breast surgery. However this intraoperative biopsy comes with certain risks such as arm swelling or lymphedema, arm pain, arm numbness/tingling, and/or psychological distress from waiting for the results or the possibility of further interventions. In order to avoid this and have a result before surgery, this study will explore a nonsurgical method of sampling these lymph nodes. Normally suspicious lymph nodes are hard to find accurately by exam and ultrasound.\n\nA new method has been developed that involves injecting a small amount of iron dissolved in liquid into the breast that gets absorbed by the lymph nodes making them bright on ultrasound and possible to biopsy. This method has been shown to have results as accurate as standard sentinel lymph node biopsy by comparing them in the operating room. This study will now investigate performing these ultrasounds and biopsies in the office as well as compare these results to the results of the standard sentinel lymph node biopsy in the operating room. The results of this study could help future breast cancer patients to avoid invasive sampling and all of the accompanying risk as well as give patients and the care team an idea of the extent of disease sooner in order to guide management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients at least 21 years old\n* Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy\n* Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including:\n* Patients having a mastectomy\n* Patients with palpable DCIS\n* Patients undergoing breast conservation with large (\\>5cm) area of DCIS\n* Patients with signed consent to participate\n\nExclusion Criteria:\n\n* Preoperative palpable axillary lymphadenopathy\n* Preoperative ultrasound demonstrating suspicious adenopathy\n* Previous axillary dissection or previous lymph node biopsy\n* Patients with Invasive Lobular Carcinoma\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT02610920', 'briefTitle': 'Sentinel Lymph Node Identification in the Axilla of Women With Breast Cancer Using Ultrasound and Iron Injection', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer', 'orgStudyIdInfo': {'id': 'AAAP8967'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron-tracer Injection and Biopsy', 'description': 'Single injection of 30mg of iron sucrose followed by axillary ultrasound-guided biopsy of lymph node within 2 hours.', 'interventionNames': ['Procedure: Iron-tracer guided axillary ultrasound and biopsy', 'Drug: Iron tracer']}], 'interventions': [{'name': 'Iron-tracer guided axillary ultrasound and biopsy', 'type': 'PROCEDURE', 'description': 'After ultrasound identifying sentinel lymph nodes, no more than two nodes will be core-needle biopsied and sent to pathology department for analysis of cancer involvement. The biopsied node(s) will be marked for later identification for the surgeons during the regularly scheduled intraoperative sentinel lymph node biopsy (standard of care).', 'armGroupLabels': ['Iron-tracer Injection and Biopsy']}, {'name': 'Iron tracer', 'type': 'DRUG', 'otherNames': ['Venofer', '75010550'], 'description': 'All participants will receive a 30mg injection of subcutaneous iron sucrose into the breast followed by an axillary ultrasound looking for lymph nodes with enhanced reflexivity.', 'armGroupLabels': ['Iron-tracer Injection and Biopsy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bret Taback, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}