Three-dimensional Ultrasonography Thyroid Volume Measurement.
Primary Purpose
Thyroid, Thyroid Cancer, Thyroid Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
BK 5000 Ultrasound Machine
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid focused on measuring Ultrasound, Ultrasonography, Volumetry, Thyroid Gland, Three Dimensional, 3D
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.
Sites / Locations
- RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Thyroidectomy
Arm Description
Patients set for total thyroidectomy incl. functional total thyroidectomies.
Outcomes
Primary Outcome Measures
Thyroid volume
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
Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound
Interobserver variability
Variation in volume estimation when delineating ultrasound images.
Full Information
NCT ID
NCT05510609
First Posted
August 19, 2022
Last Updated
August 19, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05510609
Brief Title
Three-dimensional Ultrasonography Thyroid Volume Measurement.
Official Title
Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, Thyroid Cancer, Thyroid Diseases, Graves Disease, Thyroid Goiter, Thyroid Adenoma
Keywords
Ultrasound, Ultrasonography, Volumetry, Thyroid Gland, Three Dimensional, 3D
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thyroidectomy
Arm Type
Other
Arm Description
Patients set for total thyroidectomy incl. functional total thyroidectomies.
Intervention Type
Device
Intervention Name(s)
BK 5000 Ultrasound Machine
Intervention Description
Both 2D and 3D ultrasound is being used. 3D using optical tracking.
Primary Outcome Measure Information:
Title
Thyroid volume
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Shrinkage in gland after excision
Description
Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound
Time Frame
30 minutes
Title
Interobserver variability
Description
Variation in volume estimation when delineating ultrasound images.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klara Bay Rask
Phone
+4521140978
Email
Klara.bay.rask@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Todsen, MD, PhD, Associate Professor
Phone
+4535452071
Email
tobias.todsen@regionh.dk
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Capital
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Todsen, MD, PhD, associate professor
Phone
+4535452071
Email
tobias.todsen@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Three-dimensional Ultrasonography Thyroid Volume Measurement.
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