Clinical trial · Observational
Large Language Model-Assisted cTNM Annotation From Chinese PSMA PET/CT Reports
Large Language Model-Assisted Imaging cTNM Staging Annotation and Uncertainty Recognition for Prostate Cancer Based on Chinese PSMA PET/CT Reports
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Large Language Model-Assisted Report Annotation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PSMA PET/CT Report Text Validation Cohort
- description
- Patients with prostate cancer or suspected prostate cancer who underwent PSMA PET/CT as part of routine clinical care. De-identified Chinese PSMA PET/CT report texts and necessary baseline information will be used for manual annotation, large language model-assisted imaging cTNM staging annotation, uncertainty recognition, internal validation, external validation, prospective validation, and human-AI comparison. No additional examination, treatment, or follow-up will be assigned for this study.
- interventionNames
- Other: Large Language Model-Assisted Report Annotation
Primary outcomes (1)
- measure
- Accuracy of LLM-Assisted Imaging cTNM Staging Annotation
- timeFrame
- After freezing the model and prompt versions, through completion of internal, external, and prospective validation, up to 18 months
- description
- The primary outcome is the accuracy of the large language model in identifying report-derived imaging cT, cN, and cM categories from de-identified Chinese PSMA PET/CT report texts. The LLM-generated cT\_report, cN\_report, and cM\_report will be compared with the expert consensus reference standard. Accuracy, precision, recall, F1-score, macro-F1, micro-F1, complete cTNM triplet matching rate, and confusion matrices will be calculated in the internal 300-report validation set, external validation sets, and prospective 100-report validation set.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients aged 18 years or older. 2. Patients with clinically diagnosed, pathologically diagnosed, or clinically suspected prostate cancer. 3. Patients who underwent PSMA PET/CT for initial staging, recurrence assessment, treatment response evaluation, metastatic assessment, or other clinical purposes during routine care. 4. Complete or basically complete Chinese PSMA PET/CT report text is available, including imaging findings and/or diagnostic impression. 5. The report text contains information that can be used to evaluate at least one target field, such as local prostate lesion, regional lymph nodes, non-regional lymph nodes, bone metastasis, visceral metastasis, or uncertainty expressions. 6. The research data can be de-identified and replaced by a study identification number before analysis. Exclusion Criteria: 1. PSMA PET/CT reports unrelated to prostate cancer, or reports clearly irrelevant to the research task. 2. Reports with severely missing, unreadable, or unavailable main text, imaging findings, or diagnostic impression. 3. Reports that cannot be adequately de-identified or contain residual direct personal identifiers that cannot be safely removed. 4. Duplicate records, repeated exports of the same examination, or records for which the unique report version cannot be confirmed. 5. Reports judged by the research team to be of insufficient quality for manual annotation, model evaluation, or statistical analysis.
References
Publications (0)
Data not yet available