Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

May 28, 2024 updated by: Shanghai East Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

602

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200120
        • Shanghai East Hospital, Tongji University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional biopsy group
undergo standard prostate biopsy procedures without additional technological assistance
Procedure: Non-AI-assisted
undergo standard prostate biopsy procedures without additional technological assistance
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection rate of clinically significant prostate cancer by targeted biopsy alone
Time Frame: 2-3 weeks post-biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
2-3 weeks post-biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy
Time Frame: 2-3 weeks post-biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined targeted biopsy samples
2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy alone
Time Frame: 2-3 weeks post-biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy combined with template biopsy
Time Frame: 2-3 weeks post-biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined targeted biopsy samples
2-3 weeks post-biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB-NAV-MMIF-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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