Know Cancer

or
forgot password

Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Thyroid Nodules

Thank you

Trial Information

Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Realtime-Elastography scores I-IV in thyroid nodules

Outcome Description:

Scores: I-II: benign; III-IV: malignant nodules. The sensitivity and specificity of Realtime-Elastography for the diagnosis of malignant thyroid nodules will be calculated on the basis of above-specified criteria. Cytology is used as reference method for benign nodules and histology for malignant nodules.

Safety Issue:

No

Principal Investigator

Joerg Bojunga, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum der J. W. Goethe-Universität, Frankfurt, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

JWGUHMED1-004

NCT ID:

NCT01609946

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Thyroid Nodules
  • presenting for FNAB or surgery
  • Thyroid Diseases
  • Thyroid Nodule

Name

Location