Ultrasound method to measure how soft or firm thyroid nodules are before surgery
Official title: Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal (CPMX-Thyr)
Run by Insel Gruppe AG, University Hospital Bern · NCT07102264 · Data updated 2026-11-12
We will try a painless ultrasound technique to measure how compressible (soft or firm) thyroid nodules are in adults with Bethesda IV biopsy results who are scheduled for surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | December 16, 2026 |
| Study ends | December 16, 2026 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT07102264 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) who have a thyroid nodule with a Bethesda IV cytopathology result, can give informed consent, have intact skin at the measurement site, and have BMI ≤ 35 are ideal candidates.
✕Probably not a fit
People who are pregnant or breastfeeding, have BMI over 35, have non‑intact skin at the measurement site, cannot consent, or do not have Bethesda IV nodules are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a feasibility project using an ultrasound‑assisted, non‑invasive compressibility measurement (CPMX1) performed on adult patients with a thyroid nodule and a Bethesda IV cytology result prior to planned surgical removal. Measurements are taken at the hospital imaging/ENT department before surgery and the procedure is intended to be brief and painless with intact skin required at the measurement site. Compressibility measurements will be compared to the final surgical histopathology and routine ultrasound findings to explore signal differences between benign and malignant nodules. The study excludes pregnant or breastfeeding people, those with BMI>35, or those unable to consent.
Why it matters
Potential benefit: If successful, this technique could help doctors better distinguish benign from malignant nodules and reduce unnecessary surgeries for people with indeterminate (Bethesda IV) results.
How similar studies have gone: Related ultrasound elastography techniques have shown promise but mixed accuracy for distinguishing benign from malignant thyroid nodules, and this specific compressibility approach is relatively new and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years * Patients with a thyroid node * Patients with a Bethesda IV cytopathological diagnosis of this node * Informed consent documented by signature Exclusion Criteria: * Non-intact skin at the measurement site * BMI\>35kg/m2 * Patients unable to provide informed consent * Pregnant or breastfeeding women
Where it's running
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Department of Oto-Rhino-Laryngology, Head and Neck surgery Inselspital, Bern University Hospital and University of Bern
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: PD Dr. med. Urs Borner — Insel Gruppe AG, University Hospital Bern
- Study coordinator: PD Dr. med. Urs Borner
- Email: urs.borner@insel.ch
- Phone: +41(0)316324174
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.