Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

Tongji University

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Procedure: AI-assisted; Procedure: Non-AI-assisted

Study type: Interventional

Funder types: Other

Identifiers

NCT06441292

PB-NAV-MMIF-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 602 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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602 participants in 2 patient groups

conventional biopsy group

Active Comparator group

Description:

undergo standard prostate biopsy procedures without additional technological assistance

Treatment:

Procedure: Non-AI-assisted

AI-assisted biopsy group

Experimental group

Description:

utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process

Treatment:

Procedure: AI-assisted