NCT05510609

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 19, 2022

Last Update Submit

August 19, 2022

Conditions

ThyroidThyroid CancerThyroid DiseasesGraves DiseaseThyroid GoiterThyroid Adenoma

Keywords

UltrasoundUltrasonographyVolumetryThyroid GlandThree Dimensional3D

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Shrinkage in gland after excision

    30 minutes

  • Interobserver variability

    2 hours

Study Arms (1)

Thyroidectomy

OTHER

Patients set for total thyroidectomy incl. functional total thyroidectomies.

Device: BK 5000 Ultrasound Machine

Interventions

BK 5000 Ultrasound MachineDEVICE

Both 2D and 3D ultrasound is being used. 3D using optical tracking.

Thyroidectomy

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred to Rigshospitalet to undergo a complete thyroidectomy including patients with previous hemithyroidectomy
  • Adults, 18 or older.
  • Ability to give written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Capital, 2100, Denmark

RECRUITING

Related Publications (18)

  • Reinartz P, Sabri O, Zimny M, Nowak B, Cremerius U, Setani K, Bull 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. doi: 10.1089/105072502760258695.

    PMID: 12225640RESULT

  • 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. doi: 10.1007/s00259-002-1101-1. Epub 2003 Jan 23.

    PMID: 12541136RESULT

  • 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. doi: 10.1055/s-2008-1070506. German.

    PMID: 7274082RESULT

  • Schlogl 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. doi: 10.1089/105072501750302877.

    PMID: 11442004RESULT

  • 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.

    PMID: 30534656RESULT

  • 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 software: a phantom study. Ultrasound Med Biol. 2014 Jul;40(7):1453-62. doi: 10.1016/j.ultrasmedbio.2014.02.013. Epub 2014 Apr 24.

    PMID: 24768486RESULT

  • Seifert P, Winkens T, Knichel L, Kuhnel 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.

    PMID: 31765446RESULT

  • 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.

    PMID: 34322765RESULT

  • 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. doi: 10.1089/105072504322880346.

    PMID: 15068625RESULT

  • 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. doi: 10.7863/jum.2008.27.12.1727.

    PMID: 19022998RESULT

  • Andermann P, Schlogl S, Mader 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.

    PMID: 17299648RESULT

  • 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. doi: 10.7863/jum.2012.31.2.197.

    PMID: 22298862RESULT

  • 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. doi: 10.1007/s00330-015-4193-2. Epub 2016 Jan 22.

    PMID: 26795614RESULT

  • 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. doi: 10.1016/j.ultrasmedbio.2004.09.004.

    PMID: 15588952RESULT

  • 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 reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.

    PMID: 26511519RESULT

  • 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. No abstract available.

    PMID: 24449746RESULT

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

    PMID: 2868172RESULT

  • Rask KB, Makouei F, Wessman MHJ, Kristensen TT, Todsen T. Thyroid Volume Measurement With AI-Assisted Freehand 3D Ultrasound Compared to 2D Ultrasound-A Clinical Trial. Head Neck. 2026 Jan;48(1):64-70. doi: 10.1002/hed.28267. Epub 2025 Aug 8.

    PMID: 40778496DERIVED

MeSH Terms

Conditions

Thyroid DiseasesThyroid NeoplasmsGraves DiseaseGoiter

Condition Hierarchy (Ancestors)

Endocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsExophthalmosOrbital DiseasesEye DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Klara Bay Rask

CONTACT

+4521140978Klara.bay.rask@regionh.dk

Tobias Todsen, MD, PhD, Associate Professor

CONTACT

+4535452071tobias.todsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stud.Med.

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 22, 2022

Study Start

May 9, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations

DK(1)