Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT06062992
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast-Enhanced Stereotactic Biopsy
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Vacuum assisted large core needle biopsies of the breast'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of tissue needed for CESB', 'timeFrame': '2 years', 'description': 'The investigators calculate the diagnostic yield per biopsy sample to establish to minimum amount of tissue samples needed for CESB'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '2 years', 'description': 'The investigators will establish the complication rate of CESB (for example: hematoma, technical failures, infection)'}, {'measure': 'Diagnostic results', 'timeFrame': '2 years', 'description': 'The investigators will establish the various diagnostic outcomes (pathology results) of the biopsies performed using CESB'}, {'measure': 'Patient comfort', 'timeFrame': '2 years', 'description': 'The investigators will establish the patient (dis)comfort of CESB by scoring the pain associated with this intervention on a 0-10 scale (0 no pain, 10 worst pain ever)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Mammography', 'CEM', 'Biopsy'], 'conditions': ['Breast Cancer', 'Breast Neoplasms', 'Breast Cancer Female']}, 'descriptionModule': {'briefSummary': "Contrast-enhanced mammography (CEM) is an emerging breast imaging modality that is based on dual-energy mammography and the injection of iodinated contrast agent. A typical CEM study consists of a low-energy image (equal to a FFDM image) and a recombined image (in which areas of contrast enhancement can be appreciated). However, the situation can occur that lesions are visible only on the recombined (contrast) images (in this protocol defined as 'recombined-only lesions' or ROLs). In these cases, radiologists need to perform 'contrast-enhanced stereotactic biopsy' (CESB), in which CEM is used as a targeting modality.\n\nHowever, experiences with CESB are still limited and one of the most urgent questions that need to be answered is the amount of tissue sampling that is required to reach a final diagnosis. The investigators aim to study where the cut off will be in terms of tissue sampling volume needed (i.e., number of biopsies) for a reliable diagnosis.", 'detailedDescription': "Rationale: Contrast-enhanced mammography (CEM) is an emerging breast imaging modality that is based on dual-energy mammography and the injection of iodinated contrast agent. A typical CEM study consists of a low-energy image (equal to a FFDM image) and a recombined image (in which areas of contrast enhancement can be appreciated). However, the situation can occur that lesions are visible only on the recombined (contrast) images (in this protocol defined as 'recombined-only lesions' or ROLs). In these cases, radiologists need to perform 'contrast-enhanced stereotactic biopsy' (CESB), in which CEM is used as a targeting modality.\n\nHowever, experiences with CESB are still limited and one of the most urgent questions that need to be answered is the amount of tissue sampling that is required to reach a final diagnosis. The investigators aim to study where the cut off will be in terms of tissue sampling volume needed (i.e., number of biopsies) for a reliable diagnosis.\n\nObjective: To determine the minimum number of CESB-guided tissue samples needed to establish a final histopathological biopsy diagnosis for ROLs.\n\nStudy design: Prospective, single center, observational cohort study. Study population: Non-pregnant women (\\>18 years) able to provide written informed consent and with a ROL recently observed during a regular CEM examination.\n\nIntervention: Included subject will undergo CESB, consisting of an intravenous injection of iodinated contrast agent prior to image acquisition. After administration, a contrast-enhanced stereotactic localization will be performed of the ROL to determine the location and depth of the lesion within the breast. After targeting, 18 samples will be acquired using a 9 Gauge vacuum-assistend biopsy (VAB), collected in six separate and numbered cassettes, to be able to determine the chronological order of the tissue sampling. Each specimen will be histologically analyzed in this chronological order and findings will be compared with the final histopathological result after assessment of all 18 specimens.\n\nMain study parameters/endpoints: The primary study aim will be to calculate the cumulative diagnostic yield per specimen, enabling us to define a minimum number of biopsies required (or tissue volume needed) to establish a reliable diagnosis using CESB. Secondary study outcomes will be general parameters of the biopsy procedure itself, such as patient characteristics, histopathological results, pain experienced during the procedure, and complication rates (hematoma, infection)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women recently underwent CEM in our hospital, showing a ROL. Common indications to perform a CEM examination in our hospital are: recalls from breast cancer screening, as problem-solving tool after inconclusive FFDM and/or ultrasound, breast MRI alternative, preoperative staging of breast cancer and baseline examination for women treated with neoadjuvant systemic therapy (where CEM will be used as response monitoring tool).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women \\>18 years of age;\n* Recent detection of a ROL on CEM;\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* All men (male sex);\n* Women (female sex) who are contra indicated for CESB (for example: impaired renal function, known hypersensitivity to iodinated contrast);\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT06062992', 'acronym': 'CESB', 'briefTitle': 'Contrast-Enhanced Stereotactic Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Zuyderland Medisch Centrum'}, 'officialTitle': 'Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)', 'orgStudyIdInfo': {'id': 'ZuyderlandMC_CESB'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients with 'recombined imaging only lesions' or ROLs", 'description': "Women that recently underwent CEM, which showed a suspicious breast lesion only on the recombined (enhancement) images: a 'recombined image only lesions' or ROL. These women are indicated to undergo CESB.", 'interventionNames': ['Diagnostic Test: Contrast Enhanced Stereotactic Biopsy']}], 'interventions': [{'name': 'Contrast Enhanced Stereotactic Biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Stereotactic breast biopsy using CEM as targeting modality', 'armGroupLabels': ["Patients with 'recombined imaging only lesions' or ROLs"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '6162BG', 'city': 'Sittard', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marc Lobbes, MD, PhD', 'role': 'CONTACT', 'email': 'm.lobbes@zuyderland.nl', 'phone': '+31884597777'}], 'facility': 'Zuyderland Medical Center', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}], 'centralContacts': [{'name': 'Marc Lobbes, MD, PhD', 'role': 'CONTACT', 'email': 'm.lobbes@zuyderland.nl', 'phone': '+31884597777'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'Anonymized data can be made available to other researchers.', 'accessCriteria': 'Signed agreement between institutes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zuyderland Medisch Centrum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hologic, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}