Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00582920
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2007-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From 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': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-23', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate whether routine clinical use of intravenous zoledronic acid therapy affects technetium methylidene diphosphonate (Tc-99 MDP) uptake in bone metastases.', 'timeFrame': 'January 2009'}]}, 'conditionsModule': {'keywords': ['osseous lesions', 'breast cancer', 'metastatic breast cancer'], 'conditions': ['Osseous Lesions From Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine for changes in the bone scan after treating with zoledronic acid (Zometa™). This study is designed to show if intravenous (IV) bisphosphonates, which are infused by vein, such as pamidronate (Aredia™) or zoledronic acid (Zometa™), cause changes in the result of bone scans in women with metastatic breast cancer. Both bone scans and the IV bisphosphonates are components of routine care of women with breast cancer that has spread to the bone.', 'detailedDescription': 'Presently, intravenous bisphosphonates are routinely used every 3 to 4 weeks in patients with osseous metastases from breast cancer. However, there is no data addressing the effects of intravenous bisphosphonate therapy on the results of bone scan imaging. Therefore, the first step in the collaboration between MSKCC Breast Cancer Medicine Service and Nuclear Medicine Service is to define whether or not intravenous bisphosphonate therapy affects the results of bone imaging with the standard technetium, Tc-99m MDP. Women receiving intravenous bisphosphonate therapy for breast cancer metastases involving bone at MSKCC are eligible for this diagnostic clinical is no therapeutic intent in this study.\n\nBone Scan performed before intravenous bisphosphonate therapy (baseline as clinically indicated). Ideally, the bone scan will be performed immediately before to, bisphosphonate therapy.\n\nZoledronic acid, intravenous bisphosphonate therapy (as clinically indicated)\n\nBone Scan performed within 1 day after intravenous bisphosphonate therapy (study test).\n\nNumber of lesions seen in the baseline and study test will be counted and compared for changes in imaging results induced by intravenous bisphosphonate therapy.\n\nThe number of lesions detected by bone scan pre and post therapy will be recorded and the difference will be calculated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients receiving intravenous biphosphonate therapy (zoledronic acid 4 mg or renal dose equivalent) as part of their treatment regimen, who are diagnosed with metastatic breast cancer involving surrounding bone.\n* Patients must have had prior treatment zoledronic acid (4 mg or adjusted dose for renal function) within 8 weeks.\n* The patients clinical status as assessed by a treating physician must be deemed appropriate for continuing treatment with zoledronic acid\n* The patient's clinical status, as assessed by a treating physician, must be deemed appropriate for an evaluation with a bone scan\n* The patient's medical status as assessed by a treating physician must be medically appropriate to receive zoledronic acid within the study time frame and in association with the study bone scan\n\nExclusion Criteria:\n\n* No evidence of bone metastases, or less than 3 osseous lesions felt to be consistent with bone metastases, on most recent bone scan performed for clinical indications prior to study entry.\n* Patients with illnesses, or conditions that would prevent them from understanding the nature of the study and complying with the protocol requirements"}, 'identificationModule': {'nctId': 'NCT00582920', 'briefTitle': 'Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer', 'orgStudyIdInfo': {'id': '05-133'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zometa™', 'type': 'RADIATION', 'otherNames': ['Zoledronic acid'], 'description': 'Patients who will be receiving zoledronic acid therapy and are scheduled for an extent of disease evaluation with bone scan would undergo a second bone scan within 1 day of zoledronic acid therapy to assess changes in imaging.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ravinder Grewal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}