Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-30 @ 10:52 PM
Study NCT ID:
NCT05118568
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2021-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2021-11-01', 'studyFirstSubmitQcDate': '2021-11-11', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy, Sensitivity, Specificity for breast cancer detection', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Quantification of the performance achieved by breast surgeons and pathologists for breast cancer detection in Histolog Scanner images of lumpectomy margins'}], 'secondaryOutcomes': [{'measure': 'Theoretical impact on re-operation rates', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Extrapolation of the re-operation rate reduction based on positive-margin detection achieved with the Histolog Scanner, in comparison with the local intraoperative margin assessment techniques.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Confocal Microscopy', 'Fresh Tissue Imaging', 'Intraoperative Assessment', 'Breast Conserving Surgery'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.', 'detailedDescription': 'Breast cancer is the most common cancer in women. For early-stage breast cancers, breast-conserving surgery (BCS) is applied to excise the tumor while saving surrounding healthy tissue as much as possible to avoid radical excisions and achieve better aesthetic and psychological outcomes for the patient. This surgical approach requires postoperative tumor-free margin assessment of the surgical resection in order to carry on with next steps of the patient care treatment (e.g. radiotherapy). Unfortunately, at least 20% of patient undergo more than one procedure to achieve acceptable margin status due to difficulties to identify subclinical and deep-seated tumor during BCS. During the surgery, the surgeon mainly relies on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. While these determinants enable bulk tumor assessment, they do not offer the information to adequately identify tumor infiltrates on lumpectomy margin.\n\nAn efficient intraoperative assessment of the margin may solve these issues and confocal imaging has shown some promises by providing real-time imaging of fresh tissue with the resolution sufficient to visualize microscopic tissue features. The Histolog Scanner is a recent confocal microscope designed for clinical use on large surgical specimens.\n\nThe main objective of this study is to confirm that the use of the Histolog Scanner by surgeons allows to detect breast cancer on lumpectomy margins and compare the performance of the detection with local standard-of-care intraoperative imaging techniques (ultrasound and radiography) using the final assessment performed in pathology as reference.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient are selected by breast surgeons during their standard-of-care preoperative consultations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patient ≥18 years old\n* Patient Scheduled for breast conserving surgery of invasive and/ or in situ ductal carcinoma (DCIS).\n* Patient able to read, understand and give informed consent\n\nExclusion Criteria:\n\n* Patient previously treated for ipsilateral breast cancer surgery\n* Patient with previous radiotherapy of the breast\n* Patient with multicentric breast cancer\n* Patients with planed mastectomy, tumor-adapted breast reduction\n* Patient with presurgical neo-adjuvant treatment\n* Patient is pregnant/lactating\n* Participation in any other clinical study that would affect data acquisition'}, 'identificationModule': {'nctId': 'NCT05118568', 'acronym': 'Polarhis', 'briefTitle': 'Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques', 'organization': {'class': 'INDUSTRY', 'fullName': 'SamanTree Medical SA'}, 'officialTitle': "Imaging of Lumpectomy Surface With Large Field-of-View Confocal Laser Scanning Microscope 'Histolog Scanner' for Breast Margin Assessment in Comparison With Intraoperative Imaging and Postoperative Histopathological Assessment", 'orgStudyIdInfo': {'id': 'Polarhis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Histolog Scanner', 'type': 'DEVICE', 'description': 'imaging of fresh lumpectomy specimens with the Histolog Scanner, confocal microscopy scanning medical imaging device'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paderborn', 'country': 'Germany', 'facility': 'St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}], 'overallOfficials': [{'name': 'Michael P Lux, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Vincenz-Krankenhaus GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SamanTree Medical SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'St. Vincenz Krankenhaus GmbH, Paderborn', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}