Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 11:29 AM
Study NCT ID:
NCT05730608
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-FDG PET/CT Imaging for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-02-06', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in staging and/or management due to added 18F-FDG PET/CT scan', 'timeFrame': '5 years', 'description': 'Percentage of the patients with change in staging and/or management'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Survival after 18F-FDG PET/CT scan'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female', 'Breast Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.\n\nHypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.\n\nObjectives\n\nPrimary:\n\nTo evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.\n\nSecondary:\n\n* Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.\n* Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.\n* Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.\n* Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.\n* Blood and tumor samples for molecular characterisation:'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with high risk primary or recurrent breast cancer\n* Non pregnant women \\> 18 years\n* Not receiving active treatment of other cancer types.\n* Eastern Cooperative Oncology Group (ECOG) status 0-2.\n\nExclusion Criteria:\n\n* Pregnant woman\n* Males\n* Age under 18\n* Patients receiving active treatment for other cancers\n* Poor general conditipon (ECOG 3 or higher)'}, 'identificationModule': {'nctId': 'NCT05730608', 'briefTitle': '18F-FDG PET/CT Imaging for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vestre Viken Hospital Trust'}, 'officialTitle': 'Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)', 'orgStudyIdInfo': {'id': '495077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Primary breast cancer', 'description': 'Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.', 'interventionNames': ['Other: 18F-FDG PET/CT']}, {'type': 'OTHER', 'label': 'Recurrent breast cancer', 'description': 'Patients with suspected or proven locoregional recurrent breast cancer.', 'interventionNames': ['Other: 18F-FDG PET/CT']}], 'interventions': [{'name': '18F-FDG PET/CT', 'type': 'OTHER', 'description': 'Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.', 'armGroupLabels': ['Primary breast cancer', 'Recurrent breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-3004', 'city': 'Drammen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Harald Grut, MD, PHD', 'role': 'CONTACT'}], 'facility': 'Drammen Hospital - Vestre Viken HF', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}], 'centralContacts': [{'name': 'Harald Grut, MD, PHD', 'role': 'CONTACT', 'email': 'harald.grut@gmail.com', 'phone': '004797108503'}], 'overallOfficials': [{'name': 'Harald Grut, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vestre Viken Hospital Trust'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': '10.02.23 to 31.12.32', 'ipdSharing': 'YES', 'description': 'IPD available by request (Harald Grut, harald.grut@gmail.com)', 'accessCriteria': 'IPD available by request (Harald Grut, harald.grut@gmail.com)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}