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Идёт набор NCT07505797

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

— Наблюдательное Breast Cancer Benign Breast Condition Breast Fibroadenoma Breast Neoplasms

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: ATUSA 3D Automated Breast Ultrasound System.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms. Базовые параметры: 18 лет — 94 лет · Женщины.
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

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.

Обзор

AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes. The study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden. This study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.

Вмешательства

  • Устройство ATUSA 3D Automated Breast Ultrasound System
    The ATUSA system is an FDA-cleared Class II automated breast ultrasound device used in this study for investigational data collection purposes only. The device consists of a portable automated ultrasound scanner, a wearable positioning accessory, disposable components, and associated software that acquires three-dimensional ultrasound images of the breast. In this observational registry study, ATUSA imaging is performed to collect multimodality breast imaging data and is not used to guide clinic

Первичные конечные точки

  • Type and Number of breast imaging examinations collected per participant [Срок оценки: From Enrollment to +/- 180 days]
Вторичные конечные точки (3)
  • Overall Operator satisfaction as assessed by questionnaire [Срок оценки: Day of ATUSA Imaging/Enrollment]
  • Participant satisfaction as assessed by questionnaire [Срок оценки: Day of ATUSA Imaging/Enrollment]
  • Number of participants with adverse events related to the ATUSA system [Срок оценки: Enrollment through 7 days follow-up period]

Критерии участия

Критерии включения

  • Provide written informed consent through a signed and dated consent form.
  • Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.
  • Be female, aged 18 to 94 years (inclusive).
  • Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.

Критерии исключения

  • Active skin lesions (open wounds or unhealed sores) on either breast.
  • Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.
  • Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.
  • Previous bilateral mastectomy.
  • Physical inability to maintain a supine position for 30 minutes.
  • Breast anatomy incompatible with ATUSA device specifications.
  • Recent (within 12 months) breast surgery or cancer treatment.
  • Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.
  • Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • UC Davis — Sacramento

Идентификаторы

NCT: NCT07505797 · CP0004 · 1R44CA291498

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗