Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-04-09 @ 2:18 PM
Study NCT ID:
NCT01497457
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2011-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2011-12-14', 'studyFirstSubmitQcDate': '2011-12-19', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the distance between a rectal tumor and the pouch of Douglas', 'timeFrame': 'Two years', 'description': 'Feasability of the determination of the distance between a rectal tumor and the pouch of Douglas by MR saline peritoneography:\n\n1. Visualisation of the Douglas\n2. Visualisation of the Tumor\n3. Determination of the distance between the tumor and the pouch of Douglas'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rectal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rectal adenocarcinoma\n\nExclusion Criteria:\n\n* Metastatic disease\n* under 18y patient\n* woman of childbearing age'}, 'identificationModule': {'nctId': 'NCT01497457', 'briefTitle': 'Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer', 'orgStudyIdInfo': {'id': 'B403201112604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR saline peritoneography', 'description': 'Patients that will undergo MR saline peritoneography', 'interventionNames': ['Procedure: MR saline peritoneography']}], 'interventions': [{'name': 'MR saline peritoneography', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided Intraperitoneal injection of 250cc of steril saline solution with a 22G needle, followed by rectal MR imaging', 'armGroupLabels': ['MR saline peritoneography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires St Luc - Université Catholique de Louvain', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Cristina A Dragean, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques Universitaires St Luc - Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}