Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 12:47 PM
Study NCT ID:
NCT01609920
Status:
TERMINATED
Last Update Posted:
2016-11-10
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nodal Staging in Breast Cancer With MRL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], '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': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C109932', 'term': 'gadofosveset trisodium'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'whyStopped': 'Manufacturer recently halted production of gadofosveset.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-05-30', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases', 'timeFrame': 'Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.', 'description': 'The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL as 0= benign, 1=malign. These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis. So the diagnostic performace can be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRI', 'lymph node metastases', 'breast cancer', 'gadofosveset'], 'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL).\n\nThe diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.\n2. Willing and able to undergo all study procedures\n3. Has personally provided written informed consent.\n\nExclusion Criteria:\n\n1. Age \\<18,\n2. Pregnancy\n3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.\n4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)\n5. Being unable to give informed consent in person\n6. Acute or chronic severe renal insufficiency (glomerular filtration rate \\<45 mL/min/1.73m2)1.\n7. Acute renal insufficiency of any severity due to the hepato-renal syndrome.\n8. Known (or suspicion of) QT- prolongation'}, 'identificationModule': {'nctId': 'NCT01609920', 'briefTitle': 'Nodal Staging in Breast Cancer With MRL', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset', 'orgStudyIdInfo': {'id': '12-2-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gadofosveset MRL', 'interventionNames': ['Drug: Gadofosveset enhanced MRL of axillary lymph nodes']}], 'interventions': [{'name': 'Gadofosveset enhanced MRL of axillary lymph nodes', 'type': 'DRUG', 'otherNames': ['Vasovist', 'Ablavar', 'Gadofosveset'], 'description': 'A MRL of the axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.', 'armGroupLabels': ['Gadofosveset MRL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6225 HX', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center (MUMC) AZM', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'R.G.H. Beets-Tan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}