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Набор по приглашению NCT07178080

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

Без фазы С лечением Thyroid Nodules Thyroid Nodule

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PIUR tUS Infinity Ultrasound.
Кому может быть актуально
Состояния в реестре: Thyroid Nodules, Thyroid Nodule. Базовые параметры: от 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparative Analysis of PIUR Imaging Technology for Volume Reduction Rate Measurement in Thyroid Nodule Ablations

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство PIUR 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.

Первичные конечные точки

  • Thyroid nodule volumetric measurements [Срок оценки: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year]
  • Comparison of variability between measurements [Срок оценки: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year]
  • Post-ablation thyroid volume reduction rate comparison [Срок оценки: 2 weeks, 1-, 3-, 6-, and 12 months.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Sarasota Memorial Health Care System — Sarasota

Публикации

  • 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
  • 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

Идентификаторы

NCT: NCT07178080 · 25-ONC-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗