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

NCT07707232 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4600

Last updated 2026-07-21

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-17
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707232 on ClinicalTrials.gov