Large Language Model-Assisted cTNM Annotation From Chinese PSMA PET/CT Reports
NCT07707232 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4600
Last updated 2026-07-21
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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