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Trial Title:
Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation
NCT ID:
NCT06441292
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
targeted biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
AI-assisted
Description:
utilize advanced deep learning models that integrate multi-modal image fusion from
multi-parameter ultrasound and MRI to guide the biopsy process
Arm group label:
AI-assisted biopsy group
Intervention type:
Procedure
Intervention name:
Non-AI-assisted
Description:
undergo standard prostate biopsy procedures without additional technological assistance
Arm group label:
conventional biopsy group
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age > 18
2. PSA > 4 ng/ml and/or abnormal DRE
3. Sign the informed consent
Exclusion Criteria:
1. Have acute or chronic prostatitis
2. Contraindications to prostate biopsy
3. Contraindications to MRI
4. Other reasons that not suitable for this trial
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Shanghai East Hospital, Tongji University School of Medicine
Address:
City:
Shanghai
Zip:
200120
Country:
China
Start date:
July 1, 2024
Completion date:
July 15, 2025
Lead sponsor:
Agency:
Shanghai East Hospital
Agency class:
Other
Source:
Shanghai East Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06441292
