NCT03106337

Brief Summary

As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery. Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion. The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion. The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
3 years until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 16, 2017

Completed
Last Updated

May 16, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

April 25, 2014

Results QC Date

April 13, 2017

Last Update Submit

April 13, 2017

Conditions

Thyroid NoduleFollicular Neoplasm

Keywords

ThyroidFollicular NeoplasmsBethesda SystemElastographyDoppler ultrasoundThyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)

    Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.

    Baseline (Day 0)

Study Arms (1)

Shear-Wave Elastography

EXPERIMENTAL

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

Device: Shear-Wave Elastography

Interventions

Shear-Wave ElastographyDEVICE

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

Also known as: Supersonic Aixplorer
Shear-Wave Elastography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy
  • Patients \>18 years of age

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Samir AE, Dhyani M, Anvari A, Prescott J, Halpern EF, Faquin WC, Stephen A. Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular-patterned Lesions of the Thyroid: Diagnostic Accuracy and Optimal Measurement Plane. Radiology. 2015 Nov;277(2):565-73. doi: 10.1148/radiol.2015141627. Epub 2015 May 7.

    PMID: 25955578RESULT

MeSH Terms

Conditions

Thyroid NoduleThyroid Diseases

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Results Point of Contact

Title
Antonia Stephen, MD
Organization
Massachusetts General Hospital
ASTEPHEN@PARTNERS.ORG

Study Officials

  • Antonia E. Stephen, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 10, 2017

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 16, 2017

Results First Posted

May 16, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)