Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-07 @ 12:31 AM
Study NCT ID:
NCT02882958
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate Volume on Actual MRI', 'timeFrame': 'Within one month after the fiducial placement', 'description': 'A post-procedure MRI performed within one month after the fiducial placement.'}, {'measure': 'Prostate Volume on US reconstruction', 'timeFrame': 'During the fiducial placement', 'description': 'A US 3-D sweep will be performed during the fiducial placement.'}, {'measure': 'Prostate Volume based on US/EM reconstruction', 'timeFrame': 'During the fiducial placement', 'description': 'A 3-D US sweep performed during the fiducial placement and a Electromagnetic tracking data will also be acquired at the same time, and then the two series of data will be used for US/EM reconstruction.'}]}, 'conditionsModule': {'keywords': ['Radiology'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This will be single center study. Subjects will be recruited from those referred to interventional radiology for ultrasound-guided prostate fiducial placement, or those planing to undergo ultrasound-guided prostate fiducial placement in radiotherapy clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy\n\nExclusion Criteria:\n\n* eGFR \\< 45 mL/min/1.73m2\n* recent (within 4 weeks) kidney or liver transplant\n* contraindication to prostate MRI\n* patient with cardiac pacemaker'}, 'identificationModule': {'nctId': 'NCT02882958', 'briefTitle': 'Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate', 'orgStudyIdInfo': {'id': '2015P001681'}}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anthony E. Samir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Analogic Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director, Ultrasound, Department of Radiology, Massachusetts General Hospital', 'investigatorFullName': 'Anthony Samir', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}