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

NCT07178080 | Enrolling By Invitation FDA Device

• 1 other identifier: 25-ONC-49
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Nodules; Thyroid Nodule

Keywords

thyroid nodules; benign thyroid nodule; benign thyroid nodules; thyroid ablation

Outcome Measures

Primary Outcomes (3)

• Thyroid nodule volumetric measurements

  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

  Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year

• Comparison of variability between measurements

  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

  Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year

• Post-ablation thyroid volume reduction rate comparison

  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.

  2 weeks, 1-, 3-, 6-, and 12 months.

Study Arms (2)

3D ultrasound using PIUR tUS Infinity

EXPERIMENTAL

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.

Device: PIUR tUS Infinity Ultrasound

Traditional 2D

OTHER

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.

Device: PIUR tUS Infinity Ultrasound

Interventions

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.

3D ultrasound using PIUR tUS Infinity; Traditional 2D

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarasota Memorial Health Care System: lead

Study Sites (1)

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Related Publications (3)

• Trimboli P, Castellana M, Sconfienza LM, Virili C, Pescatori LC, Cesareo R, Giorgino F, Negro R, Giovanella L, Mauri G. Efficacy of thermal ablation in benign non-functioning solid thyroid nodule: A systematic review and meta-analysis. Endocrine. 2020 Jan;67(1):35-43. doi: 10.1007/s12020-019-02019-3. Epub 2019 Jul 20.

  PMID: 31327158 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• U.S. Food and Drug Administration. 510(k) Summary for PIUR Imaging Technology

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

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

Study Officials

• Ralph Tufano, MD

  Sarasota Memorial Health Care Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a double-blinded prospective study with a crossover design. Patients will serve as their own controls and receive a 2D ultrasound followed by a 3D ultrasound using PIUR technology at baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months. For the traditional 2D ultrasound scan, the physician will perform and interpret the scan to calculate volume reduction rates, following the American Thyroid Association (ATA) Thyroid Nodule Guidelines, which is the current standard of care. The PIUR 3D ultrasound results will be blinded to the physician to avoid bias during follow-up appointments.

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 17, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 8, 2027
• Study Completion (Estimated): September 8, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)