NCT07707232 Large Language Model-Assisted cTNM Annotation From Chinese PSMA PET/CT Reports
| NCT ID | NCT07707232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,600 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,600 participants in total. It began in 2026-06-17 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07707232 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07707232 currently recruiting?
Yes, NCT07707232 is actively recruiting participants. Contact the research team at devillynch@126.com for enrollment information.
Where is the NCT07707232 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT07707232 clinical trial?
NCT07707232 is sponsored by First Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 4,600 participants.
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