Three-dimensional Ultrasonography Thyroid Volume Measurement.

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT05510609

Collaborator

(none)

Enrollment

Location

Arm

5.8

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Thyroid Cancer Thyroid Diseases Graves Disease Thyroid Goiter Thyroid Adenoma	Device: BK 5000 Ultrasound Machine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.

Actual Study Start Date :

May 9, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Thyroidectomy

Patients set for total thyroidectomy incl. functional total thyroidectomies.

Device: BK 5000 Ultrasound Machine

Both 2D and 3D ultrasound is being used. 3D using optical tracking.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

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.