Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-21 @ 2:30 PM
Study NCT ID:
NCT00367666
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-18
First Post:
2006-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Diagnostic Tools to Stage Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008327', 'term': 'Mammography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2006-08-22', 'studyFirstSubmitQcDate': '2006-08-22', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This project is aimed at investigating the relative diagnostic and synergy of four state of the art breast imaging techniques (magnetic resonance imaging (MRI), full-field digital mammography (DMAM), ultrasound, and positron emission tomography (PET)) with respect to determining the extent of breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women recently diagnosed with Breast Cancer\n* Will be undergoing surgery (after study) at the Hospital of the University of Pennsylvania\n\nExclusion Criteria:\n\n* Contraindications to MRI\n* previously diagnosed with breast cancer (in the smae breast) within the past 5 years\n* Patients with known locally advanced cancer (prior to study entry) being treated with preoperative adjuvant therapy.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT00367666', 'briefTitle': 'Using Diagnostic Tools to Stage Breast Cancer', 'nctIdAliases': ['NCT00194337'], 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Evaluation of Multimodality Breast Imaging: Lesion Staging', 'orgStudyIdInfo': {'id': 'Protocol 414500'}, 'secondaryIdInfos': [{'id': 'NIH funded'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients Diagnosed with Breast Cancer', 'interventionNames': ['Device: MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)']}], 'interventions': [{'name': 'MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)', 'type': 'DEVICE', 'armGroupLabels': ['Patients Diagnosed with Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Abass Alavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}