CClinicalTrials.gg
CompletedNCT01335828SWETHYUpdated Jan 25, 2013

Elastography Interest in the Management of Thyroid Nodules

A Phase 2/3 interventional study of Medical ultrasound device (ShearWave system) in Thyroid Nodules, sponsored by AdministrateurCIC. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-25.

Sponsored by AdministrateurCIC · Phase 2/3, Interventional, and Diagnostic

Phase
Phase 2/3
Study type
Interventional
Enrollment
125
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.

02

Conditions studied

  • Thyroid Nodules

Keywords

  • Echography
  • Elastography
  • Thyroid nodules
  • Needles punction
  • Thyroid surgery
  • Patients with thyroids nodules
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient aged over 18 years old
  • Patient affiliated to social security or similarly regime
  • Patients referred for fine needle aspiration or surgery with one or more thyroid nodules

Exclusion criteria

Exclusion Criteria:

  • Patients with too much thyroid nodules or topography too imprecise to allow unambiguous correlation between echo/elastography data and histology/cytology data
  • Patients withan echography/elastography indications cons
  • Pregnant women and lactating mothers
  • Adult unable to express their consent
  • Ward of court or under guardianship
  • Person under legal protection
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • Other
    echography/elastography

    Device: Medical ultrasound device (ShearWave system)

Interventions

  • DeviceMedical ultrasound device (ShearWave system)

    Echography (all modes) and elastography "ShearWave" system

05

What researchers measure

Primary outcomes

  1. Defined echo/elastography benignity criteria

    For ultrasound and elastography benignity criteria which will be retained, outcome focus on cytoponctions number for benin nodules can be avoided by taking into account this benign criteria

    Time frame: two and half years

Secondary outcomes

  1. Evaluate the diagnostic performance of elastography ShearWave for characterization of thyroid nodules in a population of patients referred for needle biopsy or surgery nodule thyroid

    ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.

    Time frame: two and half years

  2. Assessing the use of elastography in clinical practice

    Time frame: two and half years

06

Study locations

1 site
  • Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
    Grenoble, 38043, France
07

Registry details

Key details

Study ID
NCT01335828
Lead sponsor
AdministrateurCIC
Responsible party
AdministrateurCIC (principal investigator, University Hospital, Grenoble) — Sponsor-investigator
First posted
Apr 14, 2011
Start date
Nov 2010
Primary completion
Oct 2012
Completion
Nov 2012
Last update
Jan 25, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion