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Testing an ultrasound artificial intelligence model to help distinguish benign and malignant follicular thyroid tumours before surgery

A prospective multicentre observational diagnostic accuracy cohort study to validate Prototype-Guided Protein Representation INference from Thyroid Ultrasound (ProPRINT) for preoperative differentiation of follicular thyroid carcinoma and follicular thyroid adenoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14933505
Enrollment
1000
Registered
2026-05-16
Start date
2025-12-05
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular thyroid neoplasms

Interventions

This is a prospective, multicentre, observational, non-interventional diagnostic accuracy cohort study. Patients with thyroid nodules suspected to be follicular thyroid neoplasms on routine preoperati

Sponsors

Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Patients with a thyroid nodule suspected to be a follicular thyroid neoplasm on routine preoperative ultrasound examination 3. Patients who undergo thyroid surgery as part of routine clinical care and have a final postoperative histopathological diagnosis 4. Patients whose final postoperative histopathology confirms follicular thyroid carcinoma or follicular thyroid adenoma 5. Patients with available preoperative thyroid ultrasound images of sufficient quality for model analysis 6. Patients with available essential clinical and pathological data required for diagnostic validation 7. Patients who provide written informed consent if required by the ethics committee and local regulations

Exclusion criteria

Exclusion criteria: 1. Final postoperative histopathological diagnosis other than follicular thyroid carcinoma or follicular thyroid adenoma. 2. History of thyroid intervention before the index ultrasound examination, including thyroid surgery, radiofrequency ablation, microwave ablation, ethanol ablation, or other local treatment. 3. Poor-quality preoperative ultrasound images that preclude reliable lesion identification or model analysis, including severe artefacts, incomplete lesion coverage, or inadequate resolution. 4. Missing essential clinical, ultrasound, or pathological data required for diagnostic validation. 5. Withdrawal of consent, if consent is required.

Countries

China

Contacts

Public ContactShuixing Zhang
shui7515@126.com+86 13544597585

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026