Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 5:12 PM
Study NCT ID:
NCT01216033
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2010-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of Breast Cancer With ABY025
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm 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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Imaging of metastases', 'timeFrame': 'One year', 'description': 'Imaging of breast cancer metastases using 111-In-ABY015 for SPECT'}], 'secondaryOutcomes': [{'measure': 'Can the new molecule be used for imaging in extended studies', 'timeFrame': 'October 2010 - June 2011'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Diagnostics', 'HER2', 'Imaging', 'Metastases', 'SPECT', 'Imaging of metastases'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '15150568', 'type': 'BACKGROUND', 'citation': 'Carlsson J, Nordgren H, Sjostrom J, Wester K, Villman K, Bengtsson NO, Ostenstad B, Lundqvist H, Blomqvist C. HER2 expression in breast cancer primary tumours and corresponding metastases. Original data and literature review. Br J Cancer. 2004 Jun 14;90(12):2344-8. doi: 10.1038/sj.bjc.6601881.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding molecule 111-In-ABY025 and if that shows whether the metastases express HER2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female age \\>20 years\n* one or more known metastases localizations\n\nExclusion Criteria:\n\n* other critical disease than breast cancer\n* age ≤ 20 years'}, 'identificationModule': {'nctId': 'NCT01216033', 'acronym': 'ABY0125', 'briefTitle': 'Exploratory Study of Breast Cancer With ABY025', 'organization': {'class': 'OTHER', 'fullName': 'Biomedical Radiation Sciences'}, 'officialTitle': 'An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '111InABY025'}}, 'armsInterventionsModule': {'interventions': [{'name': '111-In-ABY-025', 'type': 'DRUG', 'description': 'Intravenous injection of the agent'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE75185', 'city': 'Uppsala', 'state': 'Uppland', 'country': 'Sweden', 'facility': 'Akademiska Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomedical Radiation Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Henrik Lindman', 'oldOrganization': 'Uppsala Akademiska Hospital'}}}}