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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPMX1 measurement | Experimental | Measurement using investigational device CPMX 1 in addition to standard of care ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPMX1 | Device | Compressibility of thyroid nodules using CPMX1 during pre surgery planning visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device safety | - The practitioner will be asked to identify any new risks arising during the measurements using the investigational device and report these in the CRF. | up to 6 months |
| Device safety | Safety of the device shall be evaluated by systematically reporting device deficiencies (DDs), adverse device events (ADEs) and Serious adverse device events (SADEs) and by monitoring the frequency and incidence of these events. | Up to 6 months |
| Device safety | The participant will be asked to rate the perceived pain scale after the examination with the investigational device using a patient questionaire (Numeric Rating Scale). | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary efficacy of CPMX1 compressability values to predict thyroid nodule malignancy. | Preliminary efficacy of compressibility values measured with the thyroid investigational system to predict a thyroid nodule's malignancy will be assessed by:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PD Dr. med. Urs Borner | Contact | +41(0)316324174 | urs.borner@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| PD Dr. med. Urs Borner | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oto-Rhino-Laryngology, Head and Neck surgery Inselspital, Bern University Hospital and University of Bern | Recruiting | Bern | 3010 | Switzerland |
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| 60 minutes |
| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D004194 | Disease |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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