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Идёт набор NCT07067788

B.Brilliant Revelation Comparision Study

— Наблюдательное Breast Cancer Screening

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: Breast Imaging.
Кому может быть актуально
Состояния в реестре: Breast Cancer Screening. Базовые параметры: от 18 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

A Clinical Comparison of Siemens Mammomat B.Brilliant , A Novel Wide-Angel Digitial Breast Tomosynthesis System With Siemens Mammomat Revelation , A Standard Wide-Angle Digital Breast Tomosynthesis System

Обзор

This is an observational study to evaluate the MAMMOMAT B.brilliant system. All diagnostic decisions are made by the treating radiologist based upon standard of care clinical imaging acquired on FDA approved devices

Подробное описание

Women scheduled at Pennsylvania Hospital to undergo a standard of care diagnostic imaging exam after having had a standard of care screening exam performed on either the MAMMOMAT B.brilliant (NDBT) or the MAMMOMAT Revelation (DBT) mammography system with findings consistent with suspicious calcifications or calcifications associated with other lesion types will be eligible and approached to enroll in the study. Participants must be ≥ 18 years of age. Up to 125 evaluable participants will be enrolled.

Eligible and consented participants enrolled in the study will receive standard of care diagnostic imaging on the same mammography system as the screening exam and receive two additional research images on the other mammography system.

Both mammographic units are FDA approved and located at Pennsylvania Hospital.

The research scans required for this study will include either 5-8 seconds or 25 seconds of compression in two views (MLO \& CC) of the affected breast (breast with suspicious calcifications at screening). Data will be collected to evaluate image quality regarding the visibility of calcifications. This study seeks to evaluate MAMMOMAT B.brilliant, which has decreased acquisition time and increased conspicuity of calcifications, as a replacement to standard wide-angle imaging as on the MAMMOMAT Revelation.

This is an observational study to evaluate the MAMMOMAT B.brilliant system. All diagnostic decisions are made by the treating radiologist based upon standard of care clinical imaging acquired on FDA approved devices

Вмешательства

  • Диагностический тест Breast Imaging
    Intervention using an FDA-approved mammogram machine.

Первичные конечные точки

  • Comparison of two Siemen System B.brillant and the Revelation [Срок оценки: From enrollment to the end of study at 18 months]
Вторичные конечные точки (2)
  • Accuracy of Calcifications and patient survey [Срок оценки: From enrollment to the end of study at 18 months]
  • Assessing the pain on two standard mammogram scanners [Срок оценки: From enrollment to the end of study at 18 months]

Критерии участия

Критерии включения

  • Participants will be ≥ 18 years of age.
  • Participants will be females (sex assigned at birth).
  • Participants will be presenting for clinical diagnostic mammography with suspicious calcifications or calcifications associated with other lesion types
  • Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Критерии исключения

  • Females who are breast-feeding will not be eligible for this study
  • Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant.
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  • Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Pennsylvania Hospital, Center for Breast Imaging — Philadelphia

Идентификаторы

NCT: NCT07067788 · 857586

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗