Comparative Analysis of PIUR Imaging Technology for Volume Reduction Rate Measurement in Thyroid Nodule Ablations
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Thyroid nodule volumetric measurements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
3D ultrasound using PIUR tUS Infinity
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.
干预措施: PIUR tUS Infinity Ultrasound (Device)
Traditional 2D
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.
干预措施: PIUR tUS Infinity Ultrasound (Device)
结局指标
主要结局
Thyroid nodule volumetric measurements
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Ralph Tufano
Principal Investigator
Sarasota Memorial Health Care System