Realtime-Elastography (RTE) and Thyroid Nodules

Johannes Vermehren

Status: Completed

Conditions: Thyroid Nodules

Treatments: Procedure: Cytology (FNAB) or Surgery; Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan

Study type: Interventional

Funder types: Other

Identifiers

NCT01609946

JWGUHMED1-004

Details and patient eligibility

About

The study is an open, prospective multicenter study. According to the statistical sample size calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the study. Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or histology obtained by surgery.

All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland, as well as Realtime Elastography of thyroid nodules.

Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate the additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.

Enrollment: 602 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with thyroid nodules ≥ 5mm in size and TSH ≥ 0,35µU/ml
• Cytology obtained by FNAB or thyroid surgery planned
• age ≥ 18 year
• signed written consent

Exclusion criteria

• Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
• Non-contractually capable persons
• Pregnancy
• Lactation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)