Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyroidectomy | Other | Patients set for total thyroidectomy incl. functional total thyroidectomies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BK 5000 Ultrasound Machine | Device | Both 2D and 3D ultrasound is being used. 3D using optical tracking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shrinkage in gland after excision | Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound | 30 minutes |
| Interobserver variability | Variation in volume estimation when delineating ultrasound images. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klara Bay Rask | Contact | +4521140978 | Klara.bay.rask@regionh.dk | |
| Tobias Todsen, MD, PhD, Associate Professor | Contact | +4535452071 | tobias.todsen@regionh.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | Capital | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12225640 | Result | 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. | |
| 12541136 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D013964 | Thyroid Neoplasms |
| D006111 | Graves Disease |
| D006042 | Goiter |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 hours |
| 7274082 | Result | 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. |
| 11442004 | Result | 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. |
| 30534656 | Result | 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. |
| 24768486 | Result | 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. |
| 31765446 | Result | 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. |
| 34322765 | Result | 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. |
| 15068625 | Result | 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. |
| 19022998 | Result | 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. |
| 17299648 | Result | 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. |
| 22298862 | Result | 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. |
| 26795614 | Result | 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. |
| 15588952 | Result | 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. |
| 26511519 | Result | 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. |
| 24449746 | Result | 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. |
| 2868172 | Result | Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. |
| 40778496 | Derived | 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. |
| D006258 |
| Head and Neck Neoplasms |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |