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AzTrials

ThyroidNCT05510609

Three-dimensional Ultrasonography Thyroid Volume Measurement.

A study testing BK 5000 Ultrasound Machine in people with Thyroid and Thyroid Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Thyroid, Thyroid Cancer, Thyroid Diseases
What is being tested?
BK 5000 Ultrasound Machine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteDenmark
Study dates
9 May 2022to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Klara Bay Rask contact

+4521140978

Klara.bay.rask@regionh.dk

Tobias Todsen, MD, PhD, Associate Professor contact

+4535452071

tobias.todsen@regionh.dk

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, Capital, 2100

    Tobias Todsen, MD, PhD, associate professor, +4535452071, tobias.todsen@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.

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.

Being tested
BK 5000 Ultrasound Machine
Keywords
Ultrasound, Ultrasonography, Volumetry, Thyroid Gland, Three Dimensional, 3D
Medical subject headings
Thyroid Diseases, Thyroid Neoplasms, Graves Disease, Goiter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BK 5000 Ultrasound MachineDevice

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

Study groups in NCT05510609
Study groupRoleWhat they receive
ThyroidectomyOtherPatients set for total thyroidectomy incl. functional total thyroidectomies.
Receives: Device: BK 5000 Ultrasound Machine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 hour

Secondary outcomes (2)

  1. Shrinkage in gland after excision

    Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound

    Measured: 30 minutes

  2. Interobserver variability

    Variation in volume estimation when delineating ultrasound images.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start9 May 2022
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05510609
Sponsor's protocol ID
H-22011900
Status last verified
Aug 2022
First submitted
19 Aug 2022
Last updated
22 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 12225640

  • 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.

    PubMed 12541136

  • 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.

    PubMed 7274082

  • 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.

    PubMed 11442004

  • 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.

    PubMed 30534656

  • 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.

    PubMed 24768486

  • 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.

    PubMed 31765446

  • 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.

    PubMed 34322765

  • 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.

    PubMed 15068625

  • 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.

    PubMed 19022998

  • 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.

    PubMed 17299648

  • 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.

    PubMed 22298862

  • 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.

    PubMed 26795614

  • 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.

    PubMed 15588952

  • 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.

    PubMed 26511519

Questions about this trial

What is this clinical trial studying?

A study testing BK 5000 Ultrasound Machine in people with Thyroid and Thyroid Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Klara Bay Rask (+4521140978, Klara.bay.rask@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thyroid volume (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05510609, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.

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