Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-18 @ 12:03 AM
Study NCT ID:
NCT01761812
Status:
TERMINATED
Last Update Posted:
2016-10-18
First Post:
2013-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C109932', 'term': 'gadofosveset trisodium'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Inadequate accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2013-01-01', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation coefficient', 'timeFrame': 'This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).', 'description': 'Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference.'}, {'measure': 'Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method', 'timeFrame': 'This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'MRI', 'Elastography', 'Gadofosveset'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy\n\nExclusion Criteria:\n\n* unable to give informed consent\n* contraindication to MRI or MRI contrast agent\n* claustrophobia\n* renal impairment\n* prior hormonal or radiation therapy for prostate cancer\n* active prostatitis\n* moderate to severe rectal inflammation\n* previous rectal surgery\n* prostate biopsy within 4 weeks of planned MRI'}, 'identificationModule': {'nctId': 'NCT01761812', 'briefTitle': 'Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset', 'orgStudyIdInfo': {'id': '334-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm study', 'interventionNames': ['Other: MRI with gadofosveset and MR elastography']}], 'interventions': [{'name': 'MRI with gadofosveset and MR elastography', 'type': 'OTHER', 'armGroupLabels': ['Single arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Masoom A Haider, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Radiologist', 'investigatorFullName': 'Masoom Haider', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}