Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 5:45 PM
Study NCT ID:
NCT00242112
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2005-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI
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': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2005-10-18', 'studyFirstSubmitQcDate': '2005-10-18', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extent and Grade of Prostate Cancer Using MRI', 'timeFrame': 'Imaging followed by pathology analysis', 'description': 'Before undergoing surgery, all patients were examined with MR imaging'}]}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer.', 'detailedDescription': 'The purpose of this study is to determine the ability of functional MRI techniques \\[High Resolution Dynamic Contrast Enhanced MRI (HR-DCE-MRI), diffusion weighted MRI (DWI) and BOLD MRI\\] to detect, measure and locate intra-prostatic cancer. 70 patients undergoing MRI for staging of prostate cancer prior to radical prostatectomy will be studied. Results of MRI obtained prior to surgery will be correlated with pathologic specimens to determine MRI accuracy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients will be recruited from the University Health Network (UHN). Eligible patients will be undergoing radical prostatectomy for prostate cancer at UHN. Patients with a contraindication to MRI or MRI contrast agents, claustrophobia, renal failure, allergy to MRI contrast agents, or prior hormonal therapy or radiation therapy for prostate cancer, a biopsy within 3 weeks of the surgical date or active prostatitis will be excluded.'}, 'identificationModule': {'nctId': 'NCT00242112', 'briefTitle': 'Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI', 'orgStudyIdInfo': {'id': '05-0387-CE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI - pathology', 'interventionNames': ['Procedure: MRI Prostate']}], 'interventions': [{'name': 'MRI Prostate', 'type': 'PROCEDURE', 'armGroupLabels': ['MRI - pathology']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Masoom Haider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}