Меню
Идёт набор NCT04904757

Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Без фазы С лечением Mammographic Breast Density Mammography

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: Contrast-enhanced spectral mammography (CESM).
Кому может быть актуально
Состояния в реестре: Mammographic Breast Density, Mammography. Базовые параметры: 40 лет — 69 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM

Обзор

The purpose of this study is to evaluate how well women may adopt a Contrast-enhanced Spectral Mammography (CESM) as their yearly breast screening test compared to the standard 2-D or 3-D mammogram.

Подробное описание

Contrast-enhanced spectral mammography (CESM) is an FDA approved tool for breast cancer detection. However, adoption into clinical practice has been slow. In this study, we will explore patient issues related to the use of CESM for breast cancer screening. For this study, 210 women with heterogeneous or dense breast tissue reported on a previous mammogram, will be recruited to undergo a screening Contrast-enhanced Spectral Mammography (CESM). The CESM will serve as the subject's annual screening breast exam for clinical care. A survey will be administered before and after the examination that evaluates the patient experience. Women will not be at high risk for breast cancer (\<20% lifetime risk). All abnormal findings will be acted upon independently. Results of the general screening population survey will be compared with those of women who choose to undergo the CESM examination in order to evaluate the influence of age, education, and lifetime risk on decision making about advanced screening.

Вмешательства

  • Устройство Contrast-enhanced spectral mammography (CESM)
    CESM is a mammogram performed after the injection of IV contrast. CESM is used most often when additional information is needed after a standard mammogram. CESM has also been used to determine the extent of a known breast cancer, to screen patients at high risk for developing breast cancer due to a family history or positive cancer genes, and for women with dense breast tissue. Two images are taken almost at the same time during the exam, after the iodine based contrast injection is administered

Первичные конечные точки

  • Evaluate the patient experience during a screening CESM [Срок оценки: 16 months]
Вторичные конечные точки (1)
  • determine if there is an association between the willingness to undergo CESM and age, level of education, and breast cancer related risk factors. [Срок оценки: 16months]

Критерии участия

Критерии включения

  • • Female
  • 40 to 69 years
  • Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremely dense breast tissue within last 24 months
  • Scheduled for screening mammogram as part of the patient's clinical care

Критерии исключения

  • • No mammogram within last 24 months
  • Fatty or scattered fibroglandular tissue on last mammogram
  • History of allergy to iodinated contrast
  • History of renal disease or renal function abnormalities
  • Pregnant women
  • History of diabetes
  • History of paraproteinemia syndromes such as multiple myeloma
  • History of collagen vascular disease
  • History of vascular disease (coronary artery disease, myocardial infarction, carotid disease, peripheral vascular disease, or known visceral artery disease)
  • Previously identified as high risk for breast cancer (>20% lifetime risk)
  • Asthma
  • Sickle Cell Anemia
  • Currently on Dialysis

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • UVA Breast Care Center — Charlottesville

Идентификаторы

NCT: NCT04904757 · IRB#18853

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗