Graves Disease, Thyroid, Thyroid Adenoma, Thyroid Cancer, Thyroid Diseases, Thyroid Goiter
Conditions
Keywords
Ultrasound, Ultrasonography, Volumetry, Thyroid Gland, Three Dimensional, 3D
Brief summary
The purpose of this clinical trial is to investigate the accuracy of applying three-dimensional ultrasound on thyroid gland patients when determining a gland volume. The method will be compared to conventional b-mode ultrasound where three axis measurements (length, width, and depth) are evaluated in the ellipsoid model. The three dimensional (3D) method is utilizing optical tracking connected to the ultrasound image to form cross-sectional imaging. Patients enrolled in the study are set for complete thyroidectomies enabling a true volume of the gland by water displacement after excision. The aim is to find if this 3D method is more accurate in volume estimation than the ellipsoid model.
Interventions
DEVICEBK 5000 Ultrasound Machine
Both 2D and 3D ultrasound is being used. 3D using optical tracking.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients referred to Rigshospitalet to undergo a complete thyroidectomy including patients with previous hemithyroidectomy * Adults, 18 or older. * Ability to give written informed consent
Exclusion criteria
* Thyroid glands that are too enlarged causing visualization/measurement impairment with ultrasonography. * Thyroid cancer with preoperative suspected extracapsular spread. * Thyroids or lymph nodes that need frozen section examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thyroid volume | 1 hour | Obtaining thyroid volume with 2D ultrasound (length x Width x depth\*(Pi/6)) and 3D ultrasound with optical tracking and comparing the respective methods with a reference volume. Water displacement being gold standard for reference volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shrinkage in gland after excision | 30 minutes | Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound |
| Interobserver variability | 2 hours | Variation in volume estimation when delineating ultrasound images. |
Countries
Denmark
Contacts
Primary ContactKlara Bay Rask
Backup ContactTobias Todsen, MD, PhD, Associate Professor
Outcome results
None listed