Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-03-16 @ 7:36 PM
Study NCT ID:
NCT02626858
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2015-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing the Delineation of the Tumour Bed in Breast Irradiation
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-12-07', 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan.', 'timeFrame': '2 years'}, {'measure': 'the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV', 'timeFrame': '2 Years'}, {'measure': 'the volume changes over time (in case of adjuvant chemotherapy)', 'timeFrame': '2 years'}, {'measure': 'the usefulness of the surgical clips assessed by the 6 observers.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is:\n\n1. to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan.\n2. to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy.\n3. to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost.\n4. to propose new guidelines for tumour bed definition and delineation based on the study findings.', 'detailedDescription': 'Start of the study: february 2012'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.\n\nExclusion Criteria:\n\n* Metastases at time of diagnosis'}, 'identificationModule': {'nctId': 'NCT02626858', 'briefTitle': 'Optimizing the Delineation of the Tumour Bed in Breast Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Optimizing the Delineation of the Tumour Bed in Breast Irradiation', 'orgStudyIdInfo': {'id': 's54017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'extra treatment planning CT-scan', 'description': 'Extra pre-operative CT-scan for treatment planning in RT', 'interventionNames': ['Device: extra treatment planning CT-scan']}], 'interventions': [{'name': 'extra treatment planning CT-scan', 'type': 'DEVICE', 'description': 'Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.', 'armGroupLabels': ['extra treatment planning CT-scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Caroline Weltens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}