Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

NCT ID: NCT06441292

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-15

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional biopsy group

undergo standard prostate biopsy procedures without additional technological assistance

Group Type ACTIVE_COMPARATOR

Non-AI-assisted

Intervention Type PROCEDURE

undergo standard prostate biopsy procedures without additional technological assistance

AI-assisted biopsy group

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

Group Type EXPERIMENTAL

AI-assisted

Intervention Type PROCEDURE

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

Interventions

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AI-assisted

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

Intervention Type PROCEDURE

Non-AI-assisted

undergo standard prostate biopsy procedures without additional technological assistance

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai East Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai East Hospital, Tongji University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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shuaidong wang

Role: CONTACT

15102100859

haifeng wang

Role: CONTACT

13681750891

Other Identifiers

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PB-NAV-MMIF-01

Identifier Type: -

Identifier Source: org_study_id

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