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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03106337
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 27
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule; Follicular Neoplasm	Device: Shear-Wave Elastography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Multivariate Analysis of Factors Predictive of Carcinoma in Follicular Neoplasms of the Thyroid Gland
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shear-Wave Elastography Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.	Device: Shear-Wave Elastography; Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.; Other Names: Supersonic Aixplorer

Outcome Measures

Primary Outcome Measures

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy

• Patients >18 years of age

Exclusion Criteria

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Antonia E. Stephen, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonia Stephen, MD, Assistant Professor of Surgery, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03106337
• Other Study ID Numbers: 2007P001161
• First Posted: Apr 10, 2017
• Last Update Posted: May 16, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Antonia Stephen, MD, Assistant Professor of Surgery, Massachusetts General Hospital: Thyroid; Follicular Neoplasms; Bethesda System; Elastography; Doppler ultrasound; Thyroidectomy
• Additional relevant MeSH terms: Neoplasms; Thyroid Nodule; Thyroid Diseases

Study Results

Participant Flow

Arm/Group Title	Shear-Wave Elastography
Arm/Group Description	Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
Period Title: Overall Study
STARTED	35
COMPLETED	35
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Shear-Wave Elastography
Arm/Group Description	Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
Overall Participants	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (16.1)
Sex: Female, Male (Count of Participants)
Female	23 65.7%
Male	12 34.3%
Region of Enrollment (participants) [Number]
United States	35 100%

Outcome Measures

1. Primary Outcome

Title	Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)
Description	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.
Time Frame	Baseline (Day 0)

Outcome Measure Data

Analysis Population Description

All enrolled participants.

Arm/Group Title	Shear-Wave Elastography, Benign Lesions	Shear-Wave Elastography, Malignant Lesions
Arm/Group Description	Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort includes all participants with benign lesions.	Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort Includes all participants with malignant lesions.
Measure Participants	24	11
Transverse Plane	17.50 (7.65)	31.03 (13.54)
Sagittal Plane	23.64 (14.86)	32.14 (11.98)
Transverse Plane with Nodule in the Center	17.89 (9.1)	33.80 (12.50)

Adverse Events

Arm/Group Title	Shear-Wave Elastography
Arm/Group Description	Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
All Cause Mortality
	Shear-Wave Elastography
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Shear-Wave Elastography
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	Shear-Wave Elastography
	Affected / at Risk (%)	# Events
Total	0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.