Идёт набор NCT06220214

Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Ранняя фаза I С лечением Breast Cancer Locally Advanced Breast Cancer Neoadjuvant Chemotherapy HER2-positive Breast Cancer

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: CEDM, CEDBT, Omnipaque 350mgI/mL Solution for Injection.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy, HER2-positive Breast Cancer. 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

Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy

Обзор

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner. Participation may last up to 18 weeks. Study procedures for this research are: * Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery. * Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent * Let the research team record information from your medical record related to your condition and the treatment you receive. * Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.

Вмешательства

Диагностический тест CEDM
Contrast Enhanced Digital Mammography
Диагностический тест CEDBT
Contrast-Enhanced Digital Breast Tomosynthesis
Препарат Omnipaque 350mgI/mL Solution for Injection
Injection of an FDA approved iodinated contrast agent is required to undergo the imaging procedures. It is not the intent of the study to evaluate the contrast agent, but it will be administered at the time of experimental imaging.

Первичные конечные точки

Accuracy of (CEDM+CEDBT) to predict NAC treatment effects [Срок оценки: Immediately after definitive breast surgery, up to 24 weeks]

Вторичные конечные точки (1)

Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI [Срок оценки: Immediately before definitive breast surgery]

Критерии участия

Критерии включения

Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery