Contrast-enhanced ultrasound to improve scoring for thyroid cancer diagnosis
Contrast-enhanced Ultrasound Improves the Diagnostic Performance of Sonographic Risk Stratification System of Thyroid Carcinoma: Comparison Between Integrated Scoring Method and Up-and-down Scoring Method
This project will test whether adding contrast-enhanced ultrasound to gray-scale ultrasound helps doctors better tell which thyroid nodules are cancerous for patients who have had biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06146764 on ClinicalTrials.gov |
What this trial studies
This multicenter retrospective study compares two ways of combining gray-scale ultrasound and contrast-enhanced ultrasound (CEUS) — an integrated scoring method and an up-and-down scoring method — for diagnosing thyroid carcinoma. Participants had thyroid nodules with a solid component ≥5 mm and underwent conventional ultrasound, CEUS, and fine-needle aspiration with a final benign or malignant diagnosis. The study follows STARD 2015 reporting standards and excludes cases with indeterminate cytology without final pathology, prior thyroid surgery or ablation, or low-quality images. Diagnostic performance metrics such as sensitivity, specificity, and accuracy will be compared between the two combined scoring approaches.
Who should consider this trial
Good fit: Ideal candidates are patients with thyroid nodules (solid component ≥5 mm) who underwent gray-scale ultrasound, CEUS, and fine-needle aspiration and have a confirmed benign or malignant diagnosis.
Not a fit: Patients with indeterminate cytology (Bethesda I, III, or IV) without final pathology, those with prior thyroid surgery or ablation, nodules under 5 mm, or low-quality ultrasound images may not benefit from the results.
Why it matters
Potential benefit: If successful, this approach could improve diagnostic accuracy for thyroid nodules and help avoid unnecessary biopsies or surgeries.
How similar studies have performed: Previous studies indicate CEUS can reveal nodule perfusion and may improve characterization, but standardized combined scoring methods are not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound; * Participants who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy; * Participants with a final benign or malignant pathological results. Exclusion Criteria: * Participants with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology； * Participants with a history of thyroid ablation or surgery; * Participants with low-quality ultrasound images.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jingliang Ruan, Ph.D. — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Jingliang Ruan, Ph.D.
- Email: ruanjl3@mail.sysu.edu.cn
- Phone: +8613694202230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.