Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Thyroid Nodule (Diagnosis)

Treatments: Device: CPMX1

Study type: Interventional

Funder types: Other

Identifiers

NCT07102264

CPMX-Thyr

Details and patient eligibility

About

The thyroid gland plays an important role in hormone regulation however, it is often prone to nodules. This is common with nodules being found in up to 68% of people in a neck ultrasound, with likelihood increasing with age. However, only about 1 in 20 nodules turns out to be cancerous.

Diagnosis of thyroid nodules starts with ultrasonic assessment, where specific features have been identified to estimate the risk of malignancy. If further examination is recommended, Fine Needle Aspiration (FNA) is performed. A needle is inserted into the nodule and the obtained subset of cells are then classified into 6 categories (Bethesda score) after examination under the microscope. While some Bethesda scores provide very accurate malignancy predictions, others like category 4, are unspecific, with risk of malignancy ranging from 25 to 40%. For these patients, about 75% are operated on even though they are not prospectively diagnosed.

Soft tissue has certain physical properties, including its compressibility, which could be quantified by measuring the pressure required to deform it. It has been found that cancerous tissue is often harder than the surrounding healthy tissue. Compremium, a Swiss company which has its headquarters in Muri bei Bern, has developed a device that can be used to measure the compressibility of tissue, similarly to palpation but providing a quantitative assessment. The present study aims to investigate the feasibility and preliminary efficacy of this new technology to predict if thyroid nodules of patients scheduled for surgical removal based on FNA analysis are malignant or not.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

CPMX1 measurement

Experimental group

Description:

Measurement using investigational device CPMX 1 in addition to standard of care ultrasound.

Treatment:

Device: CPMX1