Three-dimensional Ultrasonography Thyroid Volume Measurement.

Rigshospitalet

Status: Enrolling

Conditions: Thyroid Diseases; Thyroid Adenoma; Thyroid Goiter; Thyroid; Thyroid Cancer; Graves Disease

Treatments: Device: BK 5000 Ultrasound Machine

Study type: Interventional

Funder types: Other

Identifiers

NCT05510609

H-22011900

Details and patient eligibility

About

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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Thyroidectomy

Other group

Description:

Patients set for total thyroidectomy incl. functional total thyroidectomies.

Treatment:

Device: BK 5000 Ultrasound Machine