Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 3:06 AM
Study NCT ID:
NCT06441292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 602}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The detection rate of clinically significant prostate cancer by targeted biopsy alone', 'timeFrame': '2-3 weeks post-biopsy', 'description': 'The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples'}], 'secondaryOutcomes': [{'measure': 'The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy', 'timeFrame': '2-3 weeks post-biopsy', 'description': 'The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined targeted biopsy samples'}, {'measure': 'The detection rate of any prostate cancer by targeted biopsy alone', 'timeFrame': '2-3 weeks post-biopsy', 'description': 'The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples'}, {'measure': 'The detection rate of any prostate cancer by targeted biopsy combined with template biopsy', 'timeFrame': '2-3 weeks post-biopsy', 'description': 'The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined targeted biopsy samples'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'targeted biopsy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.', 'detailedDescription': 'This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18\n2. PSA \\> 4 ng/ml and/or abnormal DRE\n3. Sign the informed consent\n\nExclusion Criteria:\n\n1. Have acute or chronic prostatitis\n2. Contraindications to prostate biopsy\n3. Contraindications to MRI\n4. Other reasons that not suitable for this trial'}, 'identificationModule': {'nctId': 'NCT06441292', 'briefTitle': 'Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI', 'orgStudyIdInfo': {'id': 'PB-NAV-MMIF-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional biopsy group', 'description': 'undergo standard prostate biopsy procedures without additional technological assistance', 'interventionNames': ['Procedure: Non-AI-assisted']}, {'type': 'EXPERIMENTAL', 'label': 'AI-assisted biopsy group', 'description': 'utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process', 'interventionNames': ['Procedure: AI-assisted']}], 'interventions': [{'name': 'AI-assisted', 'type': 'PROCEDURE', 'description': 'utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process', 'armGroupLabels': ['AI-assisted biopsy group']}, {'name': 'Non-AI-assisted', 'type': 'PROCEDURE', 'description': 'undergo standard prostate biopsy procedures without additional technological assistance', 'armGroupLabels': ['conventional biopsy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai East Hospital, Tongji University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'shuaidong wang', 'role': 'CONTACT', 'email': 'wangshuaidong_wsd@163.com', 'phone': '15102100859'}, {'name': 'haifeng wang', 'role': 'CONTACT', 'email': 'kuohaiandrew2000@vip.sina.com.cn', 'phone': '13681750891'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}