Three-dimensional Ultrasonography Thyroid Volume Measurement.

August 19, 2022 updated by: Klara Bay Rask, Rigshospitalet, Denmark

Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Capital
      • Copenhagen, Capital, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shrinkage in gland after excision
Time Frame: 30 minutes
Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound
30 minutes
Interobserver variability
Time Frame: 2 hours
Variation in volume estimation when delineating ultrasound images.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22011900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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