Three-dimensional Ultrasonography Thyroid Volume Measurement.

Not Applicable

• Conditions: Thyroid; Graves Disease; Thyroid Adenoma; Thyroid Diseases; Thyroid Goiter; Thyroid Cancer
• Interventions: Device: BK 5000 Ultrasound Machine

• Registration Number: NCT05510609
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Status Verified: 2022-08
• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-19
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thyroidectomy	BK 5000 Ultrasound Machine	Patients set for total thyroidectomy incl. functional total thyroidectomies.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Capital, Denmark