Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 10:18 AM
Study NCT ID:
NCT02524860
Status:
UNKNOWN
Last Update Posted:
2017-03-16
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of biopsy cores positive for clinically significant cancer.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Number of men diagnosed with clinically significant and clinically insignificant cancer.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Biopsy', 'Focal Healthcare', 'Fusion Targeted Biopsy', 'High Risk Cancer', 'Imaging', 'Diagnostic', 'Ultrasound', 'Multiparametric Magnetic Resonance Imaging (MP-MRI)', 'MRI-Ultrasound Fusion', 'Focal-Fusion Bx'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.', 'detailedDescription': 'The objective of this study is to determine the effectiveness of the Focal-Fusion Bx device at finding clinically relevant prostate cancer.\n\nA multiparametric MRI examination will be carried out prior to study enrollment. Probable cancerous regions (regions of interest, ROI) will be identified, and these ROIs will be used as targets during the biopsy.\n\nThree prostate sampling methods will be conducted in the same session on all patients. These include:\n\ni) Focal-Fusion Bx targeted biopsy ii) Cognitive fusion targeted biopsy and iii) Systematic (untargeted) biopsy. Trans-rectal ultrasound (TRUS) imaging will be conducted with BK Flex Focus Ultrasound system (Analogic Corporation, Peabody, MA).\n\nPrimary hypothesis: The technique used to acquire the biopsy samples will impact the proportion of clinically relevant cancers by improving the specificity of detecting clinically significant cancers. It is hypothesized that Focal-Fusion Bx biopsies will diagnose more high risk cancers and fewer low-risk cancers than non-targeted systematic biopsies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male subjects up to 80 years of age\n* Candidates for fusion biopsy\n* Elevated PSA levels\n* MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist)\n* Subject is willing and able to read, understand and sign the Informed Consent Form document\n\nExclusion Criteria:\n\n* Previous treatment for prostate cancer\n* Any contraindication to a standard TRUS prostate biopsy procedure\n* Refusal to sign the Informed Consent document'}, 'identificationModule': {'nctId': 'NCT02524860', 'briefTitle': 'Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Focal Healthcare Inc.'}, 'officialTitle': 'Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI', 'orgStudyIdInfo': {'id': '20150330, version 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI-ultrasound fusion device', 'description': "Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging", 'interventionNames': ['Device: Focal-Fusion Bx']}], 'interventions': [{'name': 'Focal-Fusion Bx', 'type': 'DEVICE', 'otherNames': ['MRI-ultrasound fusion device'], 'description': "The Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI.", 'armGroupLabels': ['MRI-ultrasound fusion device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Urology Treatment Center (division of 21st Century Oncology, Inc.)', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}], 'overallOfficials': [{'name': 'Winston Barzell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '21st Century Oncology, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Focal Healthcare Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}