Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:03 AM
Study NCT ID:
NCT07428720
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axillary Lymph Node Changes After Neoadjuvant Therapy In Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-group study evaluating ultrasound elastography for identification of metastases or regressive changes in removed axillary lymph nodes after neoadjuvant systemic treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 97}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST', 'timeFrame': 'Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).', 'description': 'Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of residual metastatic disease after neoadjuvant systemic treatment (NAST), using histopathological examination of excised lymph nodes as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), positive predictive value (PPV, %), and negative predictive value (NPV, %).'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Regressive Posttreatment Changes in Axillary Lymph Nodes After NAST', 'timeFrame': 'Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).', 'description': 'Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of regressive posttreatment changes after neoadjuvant systemic treatment (NAST), using histopathological examination as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), PPV (%), and NPV (%).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound Elastography', 'Axillary Lymph Nodes', 'Neoadjuvant Systemic Treatment'], 'conditions': ['Breast Cancer', 'Axillary Lymph Node Metastasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography.', 'detailedDescription': 'This study aims to optimize regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment (NAST). Ultrasound elastography will be validated as a method for identifying metastases or regressive posttreatment changes in removed axillary lymph nodes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Histologically confirmed breast cancer\n* Clinically positive axillary lymph nodes before neoadjuvant systemic treatment (cN+)\n* Completed neoadjuvant systemic treatment (NAST)\n* Planned axillary surgery (sentinel lymph node biopsy and/or axillary lymph node dissection)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Male patients\n* Metastatic disease at diagnosis\n* Inflammatory breast cancer\n* New primary breast cancer\n* Bilateral breast cancer\n* Pregnancy\n* Previous breast or axillary surgery'}, 'identificationModule': {'nctId': 'NCT07428720', 'briefTitle': 'Axillary Lymph Node Changes After Neoadjuvant Therapy In Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Implications Of Posttreatment Changes In Axillary Lymph Nodes And Axillary Surgical Procedure Optimization In Breast Cancer Patients After Neoadjuvant Systemic Treatment', 'orgStudyIdInfo': {'id': 'ERID-KSOPKR-0041/2022'}, 'secondaryIdInfos': [{'id': '0120-178/2022/3', 'type': 'OTHER', 'domain': 'National Medical Ethics Committee of the Republic of Slovenia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound Elastography Assessment', 'description': 'Breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment undergo ultrasound elastography assessment to identify metastases or regressive changes in axillary lymph nodes.', 'interventionNames': ['Device: Ultrasound Elastography']}], 'interventions': [{'name': 'Ultrasound Elastography', 'type': 'DEVICE', 'description': 'Ultrasound elastography is used to assess axillary lymph nodes in order to identify metastases or regressive posttreatment changes after neoadjuvant systemic treatment.', 'armGroupLabels': ['Ultrasound Elastography Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}