Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-01 @ 6:43 AM
Study NCT ID:
NCT06311695
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast-Enhanced Spectral Mammography (CESM)
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 263}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of negative predictive value (NPV) of the CEM', 'timeFrame': '1 month', 'description': 'Assessment of diagnostic accuracy of CEM in dense breasts considering as reference the classification obtained with VABB. Negative predictive value will be expressed as the proportion of patients classified as having no evidence of disease or Ductal Carcinoma In Situ (DCIS) at surgery among all patients with absence of contrast uptake at CEM'}], 'secondaryOutcomes': [{'measure': 'Evaluation of sensitivity of CEM', 'timeFrame': '1 month', 'description': 'Sensitivity will be expressed as the proportion of patients classified as positive with CEM, among all patients with malignant tumors classified with VABB (true positives)'}, {'measure': 'Evaluation of specificity of CEM', 'timeFrame': '1 month', 'description': 'Specificity will be expressed as the proportion of patients classified as negative with CEM, among all patients with benign tumors classified with VABB (true negatives)'}, {'measure': 'Positive Predictive Value (PPV) of CEM', 'timeFrame': '1 month', 'description': 'The positive predictive value will be expressed as the proportion of patients with malignant tumors classified with VABB among all patients classified as positive with CEM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mammography', 'enhancement', 'Contrast Enhanced Mammography'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).", 'detailedDescription': 'Breast cancer is the most diagnosed cancer in women and is one of the leading causes of morbidity and death from malignancy.\n\nImprovement in survival and quality of life of patients with breast malignancies depends on the ability of imaging to diagnose the neoplasm in its early stages.\n\nThe main focus of imaging applied to the study of the breast is to obtain a good balance between the number of false positives and false negatives in the prediction of malignancy: good diagnostic performance should be achieved in identifying even small and insidious neoplasms without requiring excessive examinations for benign findings.\n\nThe main diagnostic method of screening for breast malignancy still remains mammography also considering its quick execution and low cost: however as is well known the diagnostic performance of mammography is highly impaired, in patients with dense breasts. The reduced sensitivity of mammography in women with dense breasts can result in a significant underdiagnosis rate, failing to prevent death due to breast cancer in a non-negligible number of women. The sensitivity of mammography is reported in the literature as between 62-68% in dense breasts: such performance is far too low to ensure adequate support in the management of breast malignancy; supplemental screening should be recommended in women with dense breasts.\n\nFor this purpose, a diagnostic technique called contrast-enhanced mammography (CEM) has been developed in recent years: CEM is based on the use of an iodinated contrast medium to assess the vascularity of any breast lesions and its first use was approved in 2011 by the food and drug administration (FDA).\n\nThe diagnostic performance of CEM in detecting and predicting the malignancy of breast lesions has been evaluated in many studies that have shown very promising result: CEM seems to provide excellent performance, particularly where conventional diagnostic methods seem to be struggling: the low sensitivity of mammography in dense breasts; the high operator dependence of breast ultrasound; the high cost, the high number of false positives and the time required to perform Magnetic Resonance Imaging (MRI).\n\nThe purpose of this studt is to assess the diagnostic performance of recombined CEM image, in predicting malignancy of breast lesions in a population mainly represented by patients with dense breasts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with breast lesions, who underwent bilateral CEM\n* Histological assessment\n\nExclusion Criteria:\n\n* The subject is known to have risks of adverse effects with iodine contrast agents\n* The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination'}, 'identificationModule': {'nctId': 'NCT06311695', 'acronym': 'CESM', 'briefTitle': 'Contrast-Enhanced Spectral Mammography (CESM)', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer', 'orgStudyIdInfo': {'id': 'IEO 960'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contrast Enhanced Mammography', 'description': 'Patients underwent Contrast Enhanced Mammography', 'interventionNames': ['Device: Contrast Enhanced Mammography']}], 'interventions': [{'name': 'Contrast Enhanced Mammography', 'type': 'DEVICE', 'description': 'Contrast Enhanced Mammography', 'armGroupLabels': ['Contrast Enhanced Mammography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Nicosia, MD', 'role': 'CONTACT'}], 'facility': 'Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Enrico Cassano, MD', 'role': 'CONTACT', 'email': 'enrico.cassano@ieo.it', 'phone': '+390257489410'}, {'name': 'Luca Nicosia', 'role': 'CONTACT', 'email': 'luca.nicosia@ieo.it', 'phone': '+390257489410'}], 'overallOfficials': [{'name': 'Enrico Cassano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}