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Not yet recruiting NCT07488585

A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning

No phase Interventional Thyroid Nodules Thyroid Abnormalities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thyroid ultrasound.
Who it may be relevant to
Registry conditions: Thyroid Nodules, Thyroid Abnormalities. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning: A Pilot Study

Overview

The objective of the THYMAL 01 pilot study is to evaluate the Sound Blade Imaging System in subjects with benign thyroid nodules undergoing standard-of-care ultrasound imaging.

Interventions

  • Diagnostic test Thyroid ultrasound
    Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound.

Primary outcome measures

  • The Ability to Visualization Thyroid Nodules and other key Anatomical Structures [Time frame: Day 1]
  • Evaluate the visibility/detection performance of a machine-learning model [Time frame: Day 1]
  • Evaluate the segmentation performance of a machine-learning model [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07488585 · THYMAL 01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗