Three-dimensional Ultrasonography Thyroid Volume Measurement.

Study Overview
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Brief Summary
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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.

Official Title
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Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.

Conditions
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Thyroid Diseases, Graves Disease, Thyroid, Thyroid Cancer, Thyroid Goiter, Thyroid Adenoma

Intervention / Treatment
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* Device: BK 5000 Ultrasound Machine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Thyroidectomy<br>Patients set for total thyroidectomy incl. functional total thyroidectomies. | Device: BK 5000 Ultrasound Machine<br>* Both 2D and 3D ultrasound is being used. 3D using optical tracking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid volume | 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. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shrinkage in gland after excision | Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound | 30 minutes | 
| Interobserver variability | Variation in volume estimation when delineating ultrasound images. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Ultrasonography, Volumetry, Thyroid Gland, Three Dimensional, 3D