Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-28 @ 2:51 AM
Study NCT ID:
NCT06321666
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone
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': 58}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan', 'timeFrame': '36 months', 'description': 'Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic breast cancer', 'whole body magnetic resonance imaging'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.', 'detailedDescription': 'This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points.\n\n* A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed.\n* CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3).\n* At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression.\n\nPatients will be reviewed in outpatient clinic:\n\n* At baseline\n* Every 12 weeks until week 96, with the results of their recent scans.\n* As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit.\n\nAt the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of breast cancer\n* Single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted)\n* Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)\n* Aged 18 and over\n* Life expectancy of over 6 months\n* No current active malignancy other than breast cancer\n\nExclusion Criteria:\n\n* Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis\n* Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT\n* Pregnancy\n* Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.'}, 'identificationModule': {'nctId': 'NCT06321666', 'acronym': 'RESPECT-MI', 'briefTitle': 'Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI', 'orgStudyIdInfo': {'id': 'IEO 0986'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'WB-MRI and CT Scan', 'description': 'CT scan (neck/thorax/abdomen/pelvis) and WB-MRI', 'interventionNames': ['Other: WB-MRI']}], 'interventions': [{'name': 'WB-MRI', 'type': 'OTHER', 'description': 'All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI', 'armGroupLabels': ['WB-MRI and CT Scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'IEO Istituto Europeo di Oncologia', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Giuseppe Petralia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}