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Clinical Trials/NCT05510609
NCT05510609
Unknown
Not Applicable

Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.

Rigshospitalet, Denmark1 site in 1 country17 target enrollmentMay 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid
Sponsor
Rigshospitalet, Denmark
Enrollment
17
Locations
1
Primary Endpoint
Thyroid volume
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
November 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Klara Bay Rask

Stud.Med.

Rigshospitalet, Denmark

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.

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)

Study Sites (1)

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