Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT04437602
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Randomized Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with change of primary treatment due to findings at additional CEM', 'timeFrame': 'Within two months after diagnosis of breast cancer', 'description': 'Mastectomy instead of partial mastectomy due to findings of multifocal disease, mastectomy instead of partial mastectomy due to larger unifocal extent, partial mastectomy instead of mastectomy due to improved demarcation of tumour area, bilateral surgery due to findings of contralateral cancer, primary neoadjuvant treatment instead of primary surgery due to more advanced disease'}], 'secondaryOutcomes': [{'measure': 'Rate of reoperations', 'timeFrame': 'Within three months after diagnosis of breast cancer', 'description': 'Number of reoperations due to inadequate margins'}, {'measure': 'Rate of avoidable mastectomies', 'timeFrame': 'Within three months after diagnosis of breast cancer', 'description': 'Patients operated with mastectomy where histopathology shows extent less than 3 cm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Contrast Enhanced Mammography', 'Preoperative staging'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34663236', 'type': 'BACKGROUND', 'citation': 'Ahsberg K, Gardfjell A, Nimeus E, Ryden L, Zackrisson S. The PROCEM study protocol: Added value of preoperative contrast-enhanced mammography in staging of malignant breast lesions - a prospective randomized multicenter study. BMC Cancer. 2021 Oct 18;21(1):1115. doi: 10.1186/s12885-021-08832-2.'}, {'pmid': '32438917', 'type': 'RESULT', 'citation': 'Ahsberg K, Gardfjell A, Nimeus E, Rasmussen R, Behmer C, Zackrisson S, Ryden L. Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study. World J Surg Oncol. 2020 May 21;18(1):100. doi: 10.1186/s12957-020-01865-0.'}]}, 'descriptionModule': {'briefSummary': 'Patients diagnosed with breast cancer after routine assessment with digital mammography and ultrasound and scheduled for primary surgery are included in the trial. The patients are randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a) mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy instead of primary surgery due to more advanced disease. Rate of reoperation and rate of avoidable mastectomies are secondary endpoints.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Breast cancer is very uncommon among men.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned primary surgery for suspicious or verified breast malignancy Age of 18 years and above Signed informed consent\n\nExclusion Criteria:\n\n* Planned neoadjuvant therapy On-going pregnancy Iodinated contrast agent allergy Renal failure (abnormal S-creatinine) Untreated thyreotoxicosis Severe heart failure Myastenia gravis Breast implant Local recurrence as index lesion Inability to understand and comprehend oral and written information of the study'}, 'identificationModule': {'nctId': 'NCT04437602', 'acronym': 'PROCEM', 'briefTitle': 'Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Region Halland'}, 'officialTitle': 'Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial', 'orgStudyIdInfo': {'id': '2019-02661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CEM', 'description': 'Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography', 'interventionNames': ['Diagnostic Test: Contrast Enhanced Mammography (CEM)']}, {'type': 'NO_INTERVENTION', 'label': 'No CEM', 'description': 'Patients in No intervention arm will go through no additional preoperative imaging'}], 'interventions': [{'name': 'Contrast Enhanced Mammography (CEM)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Additional CEM in preoperative staging', 'armGroupLabels': ['CEM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '301 85', 'city': 'Halmstad', 'country': 'Sweden', 'facility': 'Halland Hospital Halmstad', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}, {'zip': '252 23', 'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Helsingborg Hospital', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'zip': '291 33', 'city': 'Kristianstad', 'country': 'Sweden', 'facility': 'Central Hospital Kristianstad', 'geoPoint': {'lat': 56.03129, 'lon': 14.15242}}], 'overallOfficials': [{'name': 'Kristina Ahsberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Halland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Halland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}