Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT05667532
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography', 'timeFrame': 'through study completion; an average of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts', 'detailedDescription': 'Primary Objectives:\n\n* To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo screening contrast-enhanced mammography.\n* To establish a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data including data from the companion protocol PA17-0584.\n\nSecondary Objectives:\n\n* To perform within-subject comparison of the cancer detection rate between CEM and FFDM.\n* To perform within-subject comparison of the sensitivity, specificity, and recall rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a combination of LE and DBT images among women with dense breasts.\n* To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT.\n* In patients who undergo screening breast ultrasound as a standard of care, to evaluate the performance of screening ultrasound for breast cancer detection and compare it with other imaging modalities of CEM, LE images, and DBT.\n\nExploratory Objectives:\n\n* To combine imaging, blood biomarkers, health measurements and questionnaire data for assessment of breast cancer risk.\n* To evaluate if the intensity of background parenchymal enhancement on CEM predicts breast cancer risk in women with dense breasts.\n* To evaluate if patients consider CEM as a potentially acceptable imaging modality for routine breast cancer screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites\n2. Willingness to co-enroll or currently enrolled in PA17-0584\n3. Willingness to participate in the study and ability to provide informed consent\n\nExclusion Criteria:\n\n1. Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.\n2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding\n3. Personal history of breast cancer (DCIS or invasive breast cancer)\n4. Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer\n5. Breast biopsy within 6 months\n6. Breast surgery within 12 months\n7. Breast MRI, MBI, or CEM performed within 24 months\n8. Known allergy to iodine-containing contrast agents\n9. History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast\n10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)'}, 'identificationModule': {'nctId': 'NCT05667532', 'briefTitle': 'The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts', 'orgStudyIdInfo': {'id': '2022-0651'}, 'secondaryIdInfos': [{'id': 'NCI-2022-10200', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Contrast Enhanced Mammography', 'interventionNames': ['Diagnostic Test: Contrast Enhanced Mammography']}], 'interventions': [{'name': 'Contrast Enhanced Mammography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Screening Modality', 'armGroupLabels': ['Contrast Enhanced Mammography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olena Weaver, MD', 'role': 'CONTACT', 'email': 'ooweaver@mdanderson.org', 'phone': '713-745-4555'}, {'name': 'Olena Weaver, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Olena Weaver, MD', 'role': 'CONTACT', 'email': 'ooweaver@mdanderson.org', 'phone': '(713) 745-4555'}], 'overallOfficials': [{'name': 'Olena Weaver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}