Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02432820
Status:
TERMINATED
Last Update Posted:
2021-06-11
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in dose-volume histogram (DVH) indices in prostate images', 'timeFrame': '1 year', 'description': 'The overall purpose of this study is to evaluate the ability of 3D ultrasound (US) to visualize the prostate with sufficient clarity and reliability to monitor and model anatomy motion and deformation. If this research study is successful in its findings, this mode of ultrasound imaging will have the ability to be adapted for the purposes of cost-efficient prostate radiotherapy.'}, {'measure': 'Changes in dose-volume histogram (DVH) indices in bladder images', 'timeFrame': '1 year', 'description': 'The overall purpose of this study is to evaluate the ability of 3D ultrasound (US) to visualize the bladder with sufficient clarity and reliability to monitor and model anatomy motion and deformation. If this research study is successful in its findings, this mode of ultrasound imaging will have the ability to be adapted for the purposes of cost-efficient prostate radiotherapy.'}, {'measure': 'Changes in dose-volume histogram (DVH) indices in rectal wall images', 'timeFrame': '1 year', 'description': 'The overall purpose of this study is to evaluate the ability of 3D ultrasound (US) to visualize the rectal wall with sufficient clarity and reliability to monitor and model anatomy motion and deformation. If this research study is successful in its findings, this mode of ultrasound imaging will have the ability to be adapted for the purposes of cost-efficient prostate radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'SPECIFIC STUDY AIMS\n\n1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.\n2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.', 'detailedDescription': 'SPECIFIC STUDY AIMS\n\n1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.\n2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prostate cancer patients being treated at Stanford Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men that will undergo prostate radiotherapy as a primary treatment or post-prostatectomy.\n* Age 18 or older\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* Younger than 18 yrs old\n* Inability to provide written and spoken consent.\n* Patients with implanted actively controlled devices that may be subject to electromagnetic interference from the UroNav/PervuNav electromagnetic tracking used in the study.'}, 'identificationModule': {'nctId': 'NCT02432820', 'briefTitle': 'Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Assessment of 3D Transperineal Ultrasound Imaging With Matrix Array Transducers as a Potential Imaging Modality for Adaptive Prostate and Post-Prostatectomy Radiotherapy', 'orgStudyIdInfo': {'id': 'IRB-33012'}, 'secondaryIdInfos': [{'id': 'PROS0070', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Dimitre Hristov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Steven Hancock', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}