Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?

Официальное название

Does Supplemental Contrast-enhanced Mammography Have a Benefit in Women With a Personal History of Breast Cancer and Dense Breast Tissue? A Prospective Cohort Study.

Обзор

This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. CEM combines standard mammography with a contrast agent to better detect tumors, particularly in women with dense tissue where traditional mammograms may miss signs of cancer. The study will compare CEM with ultrasound and MRI to determine its accuracy in detecting cancer, reduce wait times for screening, and provide a more affordable option than MRI. Women who participate will have their screening done in one visit, improving convenience and access. The study will track cancer detection rates, biopsy results, and patient satisfaction over two years to evaluate the benefits of CEM for early breast cancer detection.

Подробное описание

Primary Outcome Measure: 1. Detection Rate of Breast Cancer The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.

Вмешательства

• Диагностический тест Contrast-Enhanced Mammography (CEM)
  The intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effecti

Первичные конечные точки

• Detection Rate of Breast Cancer [Срок оценки: Three years from the study start date.]

Вторичные конечные точки (2)

• Lesion Characterization [Срок оценки: Up to one year.]
• Patient Experience [Срок оценки: Immediate post-procedure.]

Критерии участия

Критерии включения

• Women presenting at Rose Ages Breast Health Center, who are currently waiting for supplemental screening Ultrasound, according to pre-established guidelines at TOH for supplemental screening.
• Women ages 50-69 years of age
• Those willing to participate in the study, sign an informed consent and undergo IV iodinated contrast injection
• Women with dense breasts (category C or D) and normal mammograms (BI-RADS 1 or 2)
• No evidence of renal disease

Критерии исключения

• Patients with renal insufficiency (reduced eGFR <20ml/min)
• Previous allergic reactions to Iodine-based contrast.
• Prior contrast allergy (CT contrast)
• Thyroid Disease

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

Диагностика

Центры проведения

Канада · 1 центр

• The Ottawa Hospital — Ottawa

Идентификаторы

NCT: NCT06993246 · OHSN- REB 20240828-01H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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