Is it Feasible to Use Data Obtained Through a Three-Dimensional Reconstructed Image to Assist in Prostate Targeted Biopsy?

NCT ID: NCT07296510

Last Updated: 2025-12-22

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

COMPLETED

Total Enrollment

436 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-10-01

Brief Summary

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Objectives:There are numerous auxiliary methods to improve the accuracy of pathology results regarding prostate biopsy. However, there is no consensus on how to achieve precise targeted biopsy. This paper explores whether using data obtained through the three-dimensional reconstructed image to locate biopsy points can assist in prostate targeted biopsy.

Methods: This study is prospective. Between January 1, 2022, and June 30, 2025, our center conducted prostate biopsies on a total of 436 patients who met the criteria for prostate biopsy and exhibited suspicious lesions (PI-RADS 3-5), totaling 471 lesions. Prior to the biopsies, 3D Slicer software was utilized to perform three-dimensional reconstructions of the pelvic organs. Three-dimensional imaging was employed to measure the biopsy path data, guiding targeted biopsies. This study combined software-assisted targeted biopsies with systematic biopsies and conducted an analysis to assess the feasibility of this approach.

Detailed Description

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Conditions

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Prostate

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Prostate biopsy

All participants underwent both targeted and systematic biopsies, along with three-dimensional reconstructed image-assisted prostate targeted biopsy,and software-assisted fusion targeted biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients meet the criteria for prostate biopsy and exhibited suspicious lesions (PI-RADS 3-5)

Exclusion Criteria

Patients with advanced prostate cancer and those with severe coagulopathy or other conditions unsuitable for prostate biopsy
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Ting Huang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jinhua Hospital, Zhejiang University School of Medicine

Jinhua, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2021120

Identifier Type: -

Identifier Source: org_study_id