Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation
Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI
1 other identifier
interventional
602
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Jul 2024
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedJune 4, 2024
May 1, 2024
12 months
May 28, 2024
May 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The detection rate of clinically significant prostate cancer by targeted biopsy alone
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
2-3 weeks post-biopsy
Secondary Outcomes (3)
The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy
2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy alone
2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy combined with template biopsy
2-3 weeks post-biopsy
Study Arms (2)
conventional biopsy group
ACTIVE COMPARATORundergo standard prostate biopsy procedures without additional technological assistance
AI-assisted biopsy group
EXPERIMENTALutilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process
Interventions
utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process
undergo standard prostate biopsy procedures without additional technological assistance
Eligibility Criteria
You may qualify if:
- Age \> 18
- PSA \> 4 ng/ml and/or abnormal DRE
- Sign the informed consent
You may not qualify if:
- Have acute or chronic prostatitis
- Contraindications to prostate biopsy
- Contraindications to MRI
- Other reasons that not suitable for this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, 200120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 4, 2024
Study Start
July 1, 2024
Primary Completion
June 30, 2025
Study Completion
July 15, 2025
Last Updated
June 4, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share