Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-01 @ 3:27 PM
Study NCT ID:
NCT01639859
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2012-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2012-06-22', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Young's modulus(kPa) of cancerous tumor foci", 'timeFrame': '2 years'}, {'measure': "Young's modulus(kPa) of normal peripheral zone", 'timeFrame': '2 years'}, {'measure': "Young's modulus(kPa) of normal transition zone", 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'elastography', 'elasticity'], 'conditions': ['Cancer of Prostate']}, 'referencesModule': {'references': [{'pmid': '27553936', 'type': 'BACKGROUND', 'citation': 'Rouviere O, Melodelima C, Hoang Dinh A, Bratan F, Pagnoux G, Sanzalone T, Crouzet S, Colombel M, Mege-Lechevallier F, Souchon R. Stiffness of benign and malignant prostate tissue measured by shear-wave elastography: a preliminary study. Eur Radiol. 2017 May;27(5):1858-1866. doi: 10.1007/s00330-016-4534-9. Epub 2016 Aug 23.'}]}, 'descriptionModule': {'briefSummary': "The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years old, with prostate cancer and scheduled for radical prostatectomy\n\nExclusion Criteria:\n\n* Medical history of prostate surgery or radiotherapy of prostate\n* Medical history of abdominal perinéanal amputation or whole of state which prevent to use endorectal probe'}, 'identificationModule': {'nctId': 'NCT01639859', 'acronym': 'PROSTATE SSI', 'briefTitle': 'Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci', 'orgStudyIdInfo': {'id': '2011.658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elastography', 'interventionNames': ['Other: Elastography']}], 'interventions': [{'name': 'Elastography', 'type': 'OTHER', 'otherNames': ['Supersonic Imagine Aixplorer scanner'], 'description': 'The elastography in vivo will be performed before the prostatectomy. The elastography ex vivo will be performed after radical prostatectomy.', 'armGroupLabels': ['Elastography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69 437', 'city': 'Lyon', 'state': 'LYON', 'country': 'France', 'facility': 'Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'ROUVIERE Olivier, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}