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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

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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

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Keywords

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

In context

Thyroid Nodule

207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.

This study's enrollment of 125 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

AdministrateurCIC is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
    Grenoble, 38043, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010, a primary completion of Oct 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2010
First posted
Apr 14, 2011
Start
Nov 2010
Primary completionActual
Oct 2012
CompletionActual
Nov 2012
Last update
Jan 25, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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.

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