The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts

Обзор

To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts

Подробное описание

Primary Objectives:

* To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo screening contrast-enhanced mammography. * To establish a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data including data from the companion protocol PA17-0584.

Secondary Objectives:

* To perform within-subject comparison of the cancer detection rate between CEM and FFDM. * To perform within-subject comparison of the sensitivity, specificity, and recall rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a combination of LE and DBT images among women with dense breasts. * To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT. * In patients who undergo screening breast ultrasound as a standard of care, to evaluate the performance of screening ultrasound for breast cancer detection and compare it with other imaging modalities of CEM, LE images, and DBT.

Exploratory Objectives:

* To combine imaging, blood biomarkers, health measurements and questionnaire data for assessment of breast cancer risk. * To evaluate if the intensity of background parenchymal enhancement on CEM predicts breast cancer risk in women with dense breasts. * To evaluate if patients consider CEM as a potentially acceptable imaging modality for routine breast cancer screening.

Вмешательства

• Диагностический тест Contrast Enhanced Mammography
  Screening Modality

Первичные конечные точки

• To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography [Срок оценки: through study completion; an average of 1 year.]

Критерии участия

Критерии включения

• Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites
• Willingness to co-enroll or currently enrolled in PA17-0584
• Willingness to participate in the study and ability to provide informed consent

Критерии исключения

• Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
• Current or recent (within the prior 6 months) history of pregnancy or breast feeding
• Personal history of breast cancer (DCIS or invasive breast cancer)
• Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
• Breast biopsy within 6 months
• Breast surgery within 12 months
• Breast MRI, MBI, or CEM performed within 24 months
• Known allergy to iodine-containing contrast agents
• History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
• Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT05667532 · 2022-0651 · NCI-2022-10200

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗