Thyroid Nodule, Thyroid Nodules
Conditions
Keywords
thyroid nodules, benign thyroid nodule, benign thyroid nodules, thyroid ablation
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.
Detailed 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.
Interventions
DEVICEPIUR tUS Infinity 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.
Sponsors
Sarasota Memorial Health Care System
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed