Clinical trial NCT03307694: Thyroid Ultrasound Elasticity (TrUE) Imaging
Official title: Multi-Angle Compound Shear Wave Elasticity Imaging for the Characterization of Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Thyroid
Keywords: Cancer
Thyroid nodule
Imaging
Radiology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from patients of the Emory Healthcare system who are scheduled to have a thyroid biopsy, thyroidectomy, or cervical node biopsy.

Brief summary: In this study the researchers will scan the thyroid nodules of patients scheduled for surgical removal of these nodules. During their preadmission testing, but prior to their surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the same ultrasound scanner and within the same imaging session without having to switch out any equipment. The results of the SWEI scans will be compared to the definitive diagnosis from pathology obtained after pathologists have examined the removed nodules post-operatively.

Detailed description: Thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules. Unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive value, for malignancy and many patients with thyroid nodules are referred for additional imaging studies or biopsy. Shear wave elasticity imaging (SWEI) is a non-invasive ultrasound technology that allows clinicians to assess the stiffness of tissues. In many solid tumors, increased stiffness is highly specific for underlying malignancy, and preliminary studies have shown this to be true for thyroid malignancies. Both standard sonography and SWEI can be performed on the same ultrasound equipment and within the same imaging session. Therefore, integrating SWEI into standard thyroid diagnostic workflow is a logical approach towards improving the positive predictive value of these first-line sonographic studies. Other studies have demonstrated the ability of SWEI techniques to differentiate benign from malignant thyroid nodules. However, shear wave techniques still need to overcome challenges before they can be successfully integrated into the clinical paradigm. These techniques still struggle to accurately classify follicular carcinomas and few have been validated in patients with multiple thyroid lesions, a scenario which is clinically common. The researchers believe that a multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To this end, this study will perform proof-of-concept studies of MAC-SWEI in thyroid patients undergoing standard ultrasound scans and compare the results of shear wave images to results from corresponding pathology.

Study participants will undergo a single SWEI session within their normally-scheduled preadmission testing during which both standard b-mode and shear images of the thyroid nodule(s) will be acquired. The 36 patients will be randomized to receive MAC-SWEI, standard SWEI, and ultrasound, or only standard SWEI and ultrasound.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy

Exclusion Criteria:

* None

Primary outcomes:
measure: Determination of Malignancy by SWEI Imaging
timeFrame: Pre-operative visit (within 24 hours before surgery, on average)
measure: Determination of Malignancy by Pathological Proof
timeFrame: Post-surgery (within 10 days after surgery, on average)
Secondary outcomes:
measure: Accuracy of differentiating benign from malignant lesions between SWEI techniques
timeFrame: Pre-operative visit (within 24 hours before surgery, on average)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Univeristy Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Stanislav Emelianov, PhD
role: PRINCIPAL_INVESTIGATOR
References: