Comparing a New 3D Technology Used to Measure Thyroid Nodule Volume to Standard Ultrasound

Sarasota Memorial Health Care System

Status: Invitation-only

Conditions: Thyroid Nodule; Thyroid Nodules

Treatments: Device: PIUR tUS Infinity Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07178080

25-ONC-49

Details and patient eligibility

About

After thyroid ablation procedure, the volume of the thyroid nodule (s) needs to be measured to see how well the procedure worked. Currently, these volumes are measured using traditional 2D ultrasound imaging. However, this approach comes with limitations because of the information 2D images cannot gather and because of differences in these measurements between different doctors. A new ultrasound technology called PIUR 3D imaging offers a novel alternative approach. The system uses advanced technology to create 3D images and can generate automated volume estimates. The PIUR imaging system, PIUR tUS Infinity, has been cleared by the Food and Drug Administration (FDA) to aid in treatment decisions when used alongside traditional 2D ultrasound imaging.

The purpose of this study is to test how effective and consistent the PIUR imaging technology is compared to standard 2D ultrasound in measuring thyroid nodule volume.

Full description

PIUR imaging technology, cleared by the U.S. Food and Drug Administration under 510(k) (K240036), is designed to provide advanced volumetric imaging capabilities to improve accuracy in assessing nodule size and volume reduction. This technology has been validated for clinical use and shown to be equivalent to conventional methods. Currently, PIUR is intended to complement the diagnostic process and should not be used as the sole basis for treatment decisions. Instead, it serves as an adjunct to standard 2D ultrasound imaging.⁸ These features make PIUR a potential candidate for post-ablation monitoring of thyroid nodules, where precision and reproducibility are critical.

This study aims to compare the volume reduction rates obtained using PIUR imaging against those calculated by an experienced clinician using traditional 2D ultrasound. The findings will help assess whether PIUR offers a more reliable, operator-independent method for evaluating treatment outcomes following thyroid nodule ablation.

Enrollment: 75 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 22 years old or older
• Patient of Dr. Ralph Tufano's office
• Undergoing thyroid nodule ablation
• The patient or their LAR must be willing and able to provide informed consent

Exclusion criteria

• Under 22 years of age
• Unable to undergo follow-up imaging
• Pregnancy
• Patients may be excluded at the physician's discretion based on their clinical judgement and/or if the health or safety of the patient may be potentially impacted by participating in this study.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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75 participants in 2 patient groups

3D ultrasound using PIUR tUS Infinity

Experimental group

Description:

Both imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another.

Treatment:

Device: PIUR tUS Infinity Ultrasound

Traditional 2D

Other group

Description:

Both imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another.

Treatment:

Device: PIUR tUS Infinity Ultrasound