Clinical trial NCT05510609: Three-dimensional Ultrasonography Thyroid Volume Measurement.
Official title: Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid
Thyroid Cancer
Thyroid Diseases
Graves Disease
Thyroid Goiter
Thyroid Adenoma
Keywords: Ultrasound
Ultrasonography
Volumetry
Thyroid Gland
Three Dimensional
3D
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Thyroid volume
timeFrame: 1 hour
Secondary outcomes:
measure: Shrinkage in gland after excision
timeFrame: 30 minutes
measure: Interobserver variability
timeFrame: 2 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Capital
Study officials:
References:
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