This Study Tests a New Sound Blade Ultrasound for Thyroid Scans. It Compares Its Images With Regular Hospital Ultrasounds to See Which is Clearer. The Images Will Help Build Future AI Tools to Improve Care.

NCT07488585 | Not Yet Recruiting

• 1 other identifier: THYMAL 01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is testing a new type of ultrasound made just for looking at the thyroid, a small gland in the neck. During one clinic visit, people will have two safe and painless scans: the regular ultrasound they would normally get, and a second scan using the research device. Both scans use a probe on the skin with gel-there are no needles, no radiation, and no changes to their medical care. The goal is to see if the new ultrasound can create clearer pictures and help computer programs find and measure thyroid nodules more accurately. In the future, this may help doctors guide treatments and make them safer and more effective.

Conditions

Thyroid Nodules; Thyroid Abnormalities

Keywords

Thyroid Nodule

Outcome Measures

Primary Outcomes (2)

• Part A: Prospective Thyroid Imaging Study Objective: Visualization and Image Quality Assessment of Key Neck Structures Using Ultrasound Visibility Scale and Radiologist Comparison Form

  1 Visibility Scale (Primary Component) Independent, blinded radiologists will rate the visibility of each structure using a 3-point scale: 0 = Not Visible (structure cannot be identified) 1. = Partially Visible (structure identifiable but with limited definition) 2. = Fully Visible (structure clearly identified with complete anatomic definition) Scores from each reviewer will be averaged for analysis. 2. Radiologist Comparative Image Quality Form (Secondary of Primary Outcome) Radiologists will complete a structured comparison form evaluating: Size (agreement between devices; measured in mm) Margins (sharp, indistinct, irregular) Edge Definition (well-defined vs. poorly defined) Overall Visibility (device-to-device comparison: better, worse, equivalent) These assessments will be recorded for each thyroid nodule and relevant neck structure. The primary endpoint is the difference in mean visibility scores and qualitative image quality ratings between the investigational and SOC ultrasound

  This will take place at month 3 to end of month 7 of study.

• Part B: Machine Learning Model Development Objective Develop and internally evaluate a machine-learning model that identifies and segments thyroid nodules and predefined neck structures (carotid, jugular, vagus nerve, trachea, thyroid nodule) on image

  Outcome Measure 1: Segmentation Accuracy Performance of the machine-learning model in segmenting thyroid nodules and neck structures (carotid artery, internal jugular vein, vagus nerve, trachea). Accuracy will be evaluated using overlap-based metrics, including the Dice Similarity Coefficient and Intersection-over-Union (IoU). These unitless measures quantify agreement between the model-generated segmentation and expert-annotated reference masks. Outcome Measure 2: Visibility and Detection Performance Performance of the model in identifying the presence or absence of thyroid nodules and key neck structures on ultrasound images. Detection quality will be assessed using standard classification metrics, including sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve (AUC). These metrics quantify diagnostic accuracy. Outcome Measure 3: 3-D Reconstruction and Focus-Tracking Feasibility Feasibility of generating consistent 3-D thyroid

  At month 4 until then end of the study, month 12.

Study Arms (1)

Participants who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound

EXPERIMENTAL

Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound after signing consent will undergo a second ultrasound using the Sound Blade Ultrasound. It will be done at the same visit, right after the SOC ultrasound is complete.

Diagnostic Test: Thyroid ultrasound

Interventions

Thyroid ultrasound DIAGNOSTIC_TEST

Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound after signing consent will undergo a second ultrasound using the Sound Blade Ultrasound. It will be done at the same visit, right after the SOC ultrasound is complete.

Participants who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be ≥ 18 years of age
• Competent to sign informed consent
• Known thyroid nodule demonstrated on a prior thyroid US and is undergoing active surveillance of the nodule with serial USs

You may not qualify if:

• Unable to lay flat for 15 minutes
• Active neck wounds, dressings, or skin conditions that would interfere with neck US (e.g., preclude transducer placement)
• Cervical spine or back disease that would prevent neck extension and would hinder the ability to obtain accurate thyroid US images
• Previous thyroid surgeries, radiation of face and neck
• Known inflammatory thyroid diseases or thyroiditis (e.g., Graves, Hashimoto)

Sponsors & Collaborators

• Sound Blade Medical Inc.: lead

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Diseases

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Study Officials

• Richard Bayls, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Wright, Project Manager, RN

CONTACT

902-225-6835; debbie.wright@nshealth.ca

Richard Balys, MD, MD

CONTACT

902-223-8032; rbalys@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To collect thyroid ultrasound scans using the Sound Blade Medical Ultrasound device and compare image quality and structure identification to standard-of-care ultrasounds.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 23, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share