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

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.

• PIUR tUS Infinity Ultrasound (Device): 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.

Primary outcomes

• Thyroid nodule volumetric measurements [Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year]: Compare thyroid nodule volumetric measurement readings retrieved from the PIUR 3D ultrasound and the volume calculated from a 2D ultrasound among patients having a thyroid ablation
• Comparison of variability between measurements [Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year]: Compare the variability in the thyroid nodule volume measurements between the PIUR 3D ultrasound and the variability calculated from a 2D ultrasound among patients having a thyroid ablation
• Post-ablation thyroid volume reduction rate comparison [2 weeks, 1-, 3-, 6-, and 12 months.]: Evaluate post-ablation thyroid volume reduction rates at 2 weeks and 1-, 3-, 6-, and 12 months in patients undergoing thyroid ablation and receiving PIUR 3D ultrasounds as compared to standard 2D ultrasounds.

Sex: All, ages: 22 Years to any

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.

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• Bernardi S, Stacul F, Zecchin M, Dobrinja C, Zanconati F, Fabris B. Radiofrequency ablation for benign thyroid nodules. J Endocrinol Invest. 2016 Sep;39(9):1003-13. doi: 10.1007/s40618-016-0469-x. Epub 2016 Apr 20. PMID 27098804
• Durante C, Grani G, Lamartina L, Filetti S, Mandel SJ, Cooper DS. The Diagnosis and Management of Thyroid Nodules: A Review. JAMA. 2018 Mar 6;319(9):914-924. doi: 10.1001/jama.2018.0898. PMID 29509871

• Ralph Tufano, MD, Principal investigator, Sarasota Memorial Health Care Systems