Ultrasound method to measure how soft or firm thyroid nodules are before surgery
Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal (CPMX-Thyr)
NA · Insel Gruppe AG, University Hospital Bern · NCT07102264
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT07102264 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bern
- 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
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.
Conditions: Thyroid Nodule