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Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid

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ClinicalTrials.gov Identifier: NCT03106337
Recruitment Status : Completed
First Posted : April 10, 2017
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Thyroid Nodule
Follicular Neoplasm
Intervention: Device: Shear-Wave Elastography

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Shear-Wave Elastography Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.

Participant Flow:   Overall Study
    Shear-Wave Elastography
STARTED   35 
COMPLETED   35 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants.

Reporting Groups
  Description
Shear-Wave Elastography Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.

Baseline Measures
   Shear-Wave Elastography 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Mean (Standard Deviation)
 55  (16.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  65.7% 
Male      12  34.3% 
Region of Enrollment 
[Units: Participants]
 
United States   35 


  Outcome Measures

1.  Primary:   Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)   [ Time Frame: Baseline (Day 0) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Antonia Stephen, MD
Organization: Massachusetts General Hospital
e-mail: ASTEPHEN@PARTNERS.ORG


Publications of Results:

Responsible Party: Antonia Stephen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03106337     History of Changes
Other Study ID Numbers: 2007P001161
First Submitted: April 25, 2014
First Posted: April 10, 2017
Results First Submitted: April 13, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017