Three-dimensional Ultrasonography Thyroid Volume Measurement.

Thyroid Cancer Clinical Trial

Official title:

Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510609
• Other study ID #: H-22011900
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2022
• Source: Rigshospitalet, Denmark
• Contact: Klara Bay Rask
• Phone: +4521140978
• Email: Klara.bay.rask[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Goiter
• Graves Disease
• Thyroid
• Thyroid Adenoma
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Goiter
• Thyroid Neoplasms

Intervention

Device:
• BK 5000 Ultrasound Machine
Both 2D and 3D ultrasound is being used. 3D using optical tracking.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Capital

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (17)

AIUM practice guideline for the performance of ultrasound examinations of the head and neck. J Ultrasound Med. 2014 Feb;33(2):366-82. doi: 10.7863/ultra.33.2.366. — View Citation

Andermann P, Schlögl S, Mäder U, Luster M, Lassmann M, Reiners C. Intra- and interobserver variability of thyroid volume measurements in healthy adults by 2D versus 3D ultrasound. Nuklearmedizin. 2007;46(1):1-7. — View Citation

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View Citation

Boers T, Braak SJ, Versluis M, Manohar S. Matrix 3D ultrasound-assisted thyroid nodule volume estimation and radiofrequency ablation: a phantom study. Eur Radiol Exp. 2021 Jul 29;5(1):31. doi: 10.1186/s41747-021-00230-4. — View Citation

Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporti — View Citation

Brunn J, Block U, Ruf G, Bos I, Kunze WP, Scriba PC. [Volumetric analysis of thyroid lobes by real-time ultrasound (author's transl)]. Dtsch Med Wochenschr. 1981 Oct 9;106(41):1338-40. German. — View Citation

Freesmeyer M, Knichel L, Kuehnel C, Winkens T. Stitching of sensor-navigated 3D ultrasound datasets for the determination of large thyroid volumes - a phantom study. Med Ultrason. 2018 Dec 8;20(4):480-486. doi: 10.11152/mu-1687. — View Citation

Freesmeyer M, Wiegand S, Schierz JH, Winkens T, Licht K. Multimodal evaluation of 2-D and 3-D ultrasound, computed tomography and magnetic resonance imaging in measurements of the thyroid volume using universally applicable cross-sectional imaging softwar — View Citation

Jang M, Kim SM, Lyou CY, Choi BS, Choi SI, Kim JH. Differentiating benign from malignant thyroid nodules: comparison of 2- and 3- dimensional sonography. J Ultrasound Med. 2012 Feb;31(2):197-204. — View Citation

Kim SC, Kim JH, Choi SH, Yun TJ, Wi JY, Kim SA, Sun HY, Ryoo I, Park SW, Sohn CH. Off-site evaluation of three-dimensional ultrasound for the diagnosis of thyroid nodules: comparison with two-dimensional ultrasound. Eur Radiol. 2016 Oct;26(10):3353-60. do — View Citation

Lyshchik A, Drozd V, Reiners C. Accuracy of three-dimensional ultrasound for thyroid volume measurement in children and adolescents. Thyroid. 2004 Feb;14(2):113-20. — View Citation

Malago R, D'Onofrio M, Ferdeghini M, Mantovani W, Colato C, Brazzarola P, Motton M, Mucelli RP. Thyroid volumetric quantification: comparative evaluation between conventional and volumetric ultrasonography. J Ultrasound Med. 2008 Dec;27(12):1727-33. — View Citation

Ng E, Chen T, Lam R, Sin D, Ying M. Three-dimensional ultrasound measurement of thyroid volume in asymptomatic male Chinese. Ultrasound Med Biol. 2004 Nov;30(11):1427-33. — View Citation

Reinartz P, Sabri O, Zimny M, Nowak B, Cremerius U, Setani K, Büll U. Thyroid volume measurement in patients prior to radioiodine therapy: comparison between three-dimensional magnetic resonance imaging and ultrasonography. Thyroid. 2002 Aug;12(8):713-7. — View Citation

Schlögl S, Werner E, Lassmann M, Terekhova J, Muffert S, Seybold S, Reiners C. The use of three-dimensional ultrasound for thyroid volumetry. Thyroid. 2001 Jun;11(6):569-74. — View Citation

Seifert P, Winkens T, Knichel L, Kühnel C, Freesmeyer M. Stitching of 3D ultrasound datasets for the determination of large thyroid volumes - phantom study part II: mechanically-swept probes. Med Ultrason. 2019 Nov 24;21(4):389-398. doi: 10.11152/mu-2006. — View Citation

van Isselt JW, de Klerk JM, van Rijk PP, van Gils AP, Polman LJ, Kamphuis C, Meijer R, Beekman FJ. Comparison of methods for thyroid volume estimation in patients with Graves' disease. Eur J Nucl Med Mol Imaging. 2003 Apr;30(4):525-31. Epub 2003 Jan 23. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour
Secondary	Shrinkage in gland after excision	Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound	30 minutes
Secondary	Interobserver variability	Variation in volume estimation when delineating ultrasound images.	2 hours