Thyroid Nodule (Diagnosis)
Conditions
Brief summary
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.
Interventions
DEVICECPMX1
Compressibility of thyroid nodules using CPMX1 during pre surgery planning visit
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device safety | up to 6 months | \- The practitioner will be asked to identify any new risks arising during the measurements using the investigational device and report these in the CRF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary efficacy of CPMX1 compressability values to predict thyroid nodule malignancy. | 60 minutes | Preliminary efficacy of compressibility values measured with the thyroid investigational system to predict a thyroid nodule's malignancy will be assessed by: 1. Computing discriminative ability and breaking down predictions into true and false positives and negatives 2. Quantification of the prospective number of surgeries if compressibility were used for clinical decision making. The thyroid's malignancy prediction will be determined by using the mean compressibility value over 5 consecutive measurements. Malignancy ground truth will be defined based on standard of care post-surgical histopathological results. |
Countries
Switzerland
Contacts
Primary ContactPD Dr. med. Urs Borner
Outcome results
None listed