Clinical trial · Interventional
Three-dimensional Ultrasonography Thyroid Volume Measurement.
Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graves Disease | — | UNRESOLVED | — |
| Thyroid | — | UNRESOLVED | — |
| Thyroid Adenoma | Thyroid Gland Follicular Adenoma | ALIAS | 0.90 |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Diseases | — | UNRESOLVED | — |
| Thyroid Goiter | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BK 5000 Ultrasound Machine | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Thyroidectomy
- description
- Patients set for total thyroidectomy incl. functional total thyroidectomies.
- interventionNames
- Device: BK 5000 Ultrasound Machine
Primary outcomes (1)
- measure
- Thyroid volume
- timeFrame
- 1 hour
- 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.
Secondary outcomes (2)
- measure
- Shrinkage in gland after excision
- timeFrame
- 30 minutes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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.
References
Publications (18)
- RESULTReinartz 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 12225640
- RESULTvan 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 12541136
- RESULTBrunn 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 7274082
- RESULTSchlogl 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 11442004
- RESULTFreesmeyer 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 30534656
- RESULTFreesmeyer 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 24768486
- RESULTSeifert 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.