Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-29 @ 5:10 PM
Study NCT ID:
NCT01062100
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2010-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '2010-02-02', 'studyFirstSubmitQcDate': '2010-02-03', 'lastUpdatePostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To explore the ability of the MBI Gamma camera to detect breast cancer.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'molecular breast imaging', 'MRI', 'gamma camera'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females ≥18 years of age\n* Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:\n\n * Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier\n * History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease)\n * History of Cowdens or Li Fraumeni Syndrome\n * A first degree relative with Cowdens or Li Fraumeni Syndrome\n * Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH)\n * Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* History of invasive breast cancer or ductal carcinoma in situ (DCIS)\n* Unable to undergo MRI because of:\n\n * Renal dysfunction with an estimated creatinine clearance of \\< 30 ml/min calculated using the Cockcroft-Gault formula\n * Implanted ferrous metal prostheses\n * Claustrophobia\n * Medical or psychological conditions that on assessment, make them unable to complete the procedure\n * Known allergies to Gadolinium-DTPA\n* Known allergies to Sestamibi (Miraluma or Cardiolite)\n* Prior bilateral mastectomy\n* Prior breast biopsy or surgery within 3 months"}, 'identificationModule': {'nctId': 'NCT01062100', 'acronym': 'THORN', 'briefTitle': 'Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera', 'organization': {'class': 'OTHER', 'fullName': 'Ontario Clinical Oncology Group (OCOG)'}, 'officialTitle': 'The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera', 'orgStudyIdInfo': {'id': 'OCOG-2009-THORN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nuclear breast imaging', 'description': 'nuclear breast imaging using MBI Gamma camera', 'interventionNames': ['Device: nuclear breast imaging using MBI Gamma camera']}], 'interventions': [{'name': 'nuclear breast imaging using MBI Gamma camera', 'type': 'DEVICE', 'description': 'nuclear breast imaging using MBI Gamma camera in addition to MRI', 'armGroupLabels': ['nuclear breast imaging']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Gregory Pond', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ontario Clinical Oncology Group - McMaster University'}, {'name': 'Karen Gulenchyn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ontario Clinical Oncology Group (OCOG)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}