Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 10:42 AM
Study NCT ID:
NCT05181059
Status:
UNKNOWN
Last Update Posted:
2022-01-06
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DLSCT for Breast Cancer Detection in Women With Dense Breasts
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual tumor conspicuity', 'timeFrame': 'On the same 1 day as the regular PET-CT scan was performed', 'description': 'The conspicuity of tumors will be graded on a 4-point confidence scale'}, {'measure': 'BI-RADS score', 'timeFrame': 'On the same 1 day as the regular PET-CT scan was performed', 'description': 'BI-RADS score according to the ACR BI-RADS lexicon'}], 'secondaryOutcomes': [{'measure': 'Iodine enhancement', 'timeFrame': 'On the same 1 day as the regular PET-CT scan was performed', 'description': 'Iodine enhancement will be measured in Hounsfield Units (HU).'}, {'measure': 'Iodine content', 'timeFrame': 'On the same 1 day as the regular PET-CT scan was performed', 'description': 'Iodine content will be measured mg/mL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms', 'Breast Density', 'Radiographic Image Interpretation, Computer-Assisted']}, 'descriptionModule': {'briefSummary': 'The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.\n\nPatients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary care clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of histopathologically proven locoregional advanced primary breast cancer:\n\n 1. Tumors \\> 5 cm (= T3) or\n 2. Tumors with invasion of the skin or chest wall (= T4) or\n 3. Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)\n* Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon\n\nExclusion Criteria:\n\n* History of allergic reactions to iodinated contrast agents\n* Pregnancy or breast feeding\n* Treatment of thyroid disease with radioactive iodine\n* Use of metformin\n* Creatinine clearance \\< 45 ml/min\n* Chronic or acutely worsening renal disease\n* Patients who are declared incompetent'}, 'identificationModule': {'nctId': 'NCT05181059', 'acronym': 'DECREAS', 'briefTitle': 'DLSCT for Breast Cancer Detection in Women With Dense Breasts', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study', 'orgStudyIdInfo': {'id': 'NL76792.091.21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dual-layer spectral computerized tomography (DLSCT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Contrast enhanced DLSCT scan using a 128-slice dual-layer detector (IQon Spectral CT, Philips Health Systems) will be performed. Patients will be placed in prone position during the DLSCT scan in order to improve the visualisation of breast tissue and comparability with MRI images. During the examination we will administer a nonionic low-osmolar iodinated contrast agent (Optiray©) in order to visualise tumor angiogenesis.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Carla A Meeuwis, MD, PhD', 'role': 'CONTACT', 'email': 'cmeeuwis@rijnstate.nl'}], 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'centralContacts': [{'name': 'Carla M Meeuwis, MD,PhD', 'role': 'CONTACT', 'email': 'cmeeuwis@rijnstate.nl', 'phone': '+31 26 378 8888'}], 'overallOfficials': [{'name': 'Laura N Deden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital'}, {'name': 'Maxime V.P. Schyns, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}