Viewing Study NCT00252460


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Study NCT ID: NCT00252460
Status: COMPLETED
Last Update Posted: 2016-03-25
First Post: 2005-11-09
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: CT/MRI Co-registration Prostate Cancer
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': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-24', 'studyFirstSubmitDate': '2005-11-09', 'studyFirstSubmitQcDate': '2005-11-09', 'lastUpdatePostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Prostatic Neoplasm']}, 'descriptionModule': {'briefSummary': 'The target volume in prostate cancer radiotherapy typically consists of the entire prostate gland which is localized by contours drawn on axial computed tomography (CT) radiation planning images. Compared with CT, magnetic resonance (MR) can provide better definition of the prostate gland with respect to the surrounding tissues and the use of multi-plannar reconstruction avoids the problem of partial volume averaging inherent in CT. CT has been shown to significantly overestimate the volume of the gland using the MR-defined prostate volume as the gold standard. Co-registration of MR and CT datasets, matched on fixed bony landmarks, has enabled radiation planning using a MR-defined clinical target volumes, combined with CT-based electron density information necessary for radiation treatment planning.\n\nRationale and Hypothesis:\n\nCo-registration may allow better delineation of tumour volumes in prostate cancer. This investigation is a fesibility study designed to evaluate and optimize imaging parameters and co-registration techniques for CT planning and MRI Simulator.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'prostate cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmation of Prostate Adenocarcinoma\n* Undergoing RT with fiducial markers, IMRT or Escalated Dose Conformal RT\n\nExclusion Criteria:\n\n* Contraindication for MRI'}, 'identificationModule': {'nctId': 'NCT00252460', 'briefTitle': 'CT/MRI Co-registration Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Evaluation of Planning Computed Tomography Scan and Magnetic Resonance Imaging Simulator Scan Co-Registration for Delineation of Gross Tumour Volume in Radiotherapy Treatment of Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'UHN REB 03-0601-CE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Computed Tomography Scan and Magnetic Resonance Imaging', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Andrew Bayley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Princess Margaret Hospital, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}