Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

Prostate Cancer Clinical Trial

Official title:

Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441292
• Other study ID #: PB-NAV-MMIF-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: May 2024
• Source: Shanghai East Hospital
• Contact: shuaidong wang
• Phone: 15102100859
• Email: wangshuaidong_wsd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 602
• Est. completion date: July 15, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• AI-assisted
utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process
• Non-AI-assisted
undergo standard prostate biopsy procedures without additional technological assistance

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy	The proportion of men with a Gleason score =3+4 in pathological assessment for combined targeted biopsy samples	2-3 weeks post-biopsy
Secondary	The detection rate of any prostate cancer by targeted biopsy alone	The proportion of men with a Gleason score =3+3 in pathological assessment for targeted biopsy samples	2-3 weeks post-biopsy
Secondary	The detection rate of any prostate cancer by targeted biopsy combined with template biopsy	The proportion of men with a Gleason score =3+3 in pathological assessment for combined targeted biopsy samples	2-3 weeks post-biopsy