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NCT07707232

Large Language Model-Assisted cTNM Annotation From Chinese PSMA PET/CT Reports

Sponsor: First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

Summary

This observational study will develop and validate a large language model-assisted workflow for imaging cTNM staging annotation and uncertainty recognition in prostate cancer using Chinese PSMA PET/CT report texts generated during routine clinical care. The study will use de-identified report texts and necessary baseline clinical information only. No additional imaging examination, blood test, treatment, or follow-up visit will be assigned for this study. The main objective is to evaluate whether a locally or institutionally controlled large language model can identify report-derived imaging cT, cN, and cM categories, extract supporting evidence from the original report, and recognize uncertainty expressions. Model performance will be assessed using an internal independent validation set, external validation reports from two collaborating hospitals, and a prospective validation set of 100 consecutive routine PSMA PET/CT reports. A human-AI comparison will also be performed using physicians from urology and imaging-related specialties with different seniority levels.

Official title: Large Language Model-Assisted Imaging cTNM Staging Annotation and Uncertainty Recognition for Prostate Cancer Based on Chinese PSMA PET/CT Reports

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4600

Start Date

2026-06-17

Completion Date

2027-12-31

Last Updated

2026-07-16

Healthy Volunteers

No

Conditions

Interventions

OTHER

Large Language Model-Assisted Report Annotation

A locally or institutionally controlled large language model workflow will analyze de-identified Chinese PSMA PET/CT report texts and generate structured outputs for report-derived imaging cTNM staging annotation, uncertainty recognition, and supporting evidence extraction. This workflow is used only for research evaluation and methodological analysis. It will not assign any examination, treatment, medication, procedure, or follow-up to participants, and it will not guide clinical diagnosis or treatment decisions.

Locations (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China