Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Thyroid volume
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Thyroid volume
Time Frame: 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 Outcomes
- Shrinkage in gland after excision(30 minutes)
- Interobserver variability(2 hours)
Investigators
Klara Bay Rask
Stud.Med.
Rigshospitalet, Denmark