Clinical trial · Interventional
Comparing a New 3D Technology Used to Measure Thyroid Nodule Volume to Standard Ultrasound
Comparative Analysis of PIUR Imaging Technology for Volume Reduction Rate Measurement in Thyroid Nodule Ablations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule | — | UNRESOLVED | — |
| Thyroid Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIUR tUS Infinity Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D ultrasound using PIUR tUS Infinity
- 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.
- interventionNames
- Device: PIUR tUS Infinity Ultrasound
- type
- OTHER
- label
- Traditional 2D
- 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.
- interventionNames
- Device: PIUR tUS Infinity Ultrasound
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDTrimboli 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
- BACKGROUNDBernardi 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
- BACKGROUNDDurante 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