Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging

Официальное название

Clinical Effectiveness of cOntrast Enhanced Mammography in Diagnosis of Additional Findings at Preoperative Breast Magnetic ResOnance Imaging: A Prospective, Multicenter, Interventional Study

Обзор

In order to explain the value of adding CESM into the clinical pathway, and also to obtain the relevant clinical data to support future update of clinical guideline, we plan to evaluate the detection rate of CESM for additional findings on preoperative breast MRI and the relevant clinical safety in the study.

Подробное описание

The goal of the prospective, multicenter, interventional Study is to prospectively evaluate the detection rate of preoperative contrast enhanced spectral mammography for additional suspicious findings of preoperative breast MRI in patients presenting with index breast lesions (BI-RADS ≥ 4).

The study plans to include 320 adult female patients with Index lesions of "BI-RADS≥4" in breast MRI.

Вмешательства

• Диагностический тест contrast-enhanced spectral mammography
  After enrollment, subjects should undergo contrast-enhanced spectral mammography again within within 28 days of MRI examination. Iopromide/contrast agent is intravenously administered two minutes prior to the first (dual-energy) image acquisition. * The dosage of iodine contrast agent is calculated as 1.5 mL/kg of iopromide 370 mgI/ml. * Injecting with high pressure syringe (Stellant, Bayer AG) at an IDR of 3ml/s, followed by 10 ml normal saline.

Первичные конечные точки

• The detection rate of preoperative contrast-enhanced spectral mammography [Срок оценки: within 28 days of MRI examination]

Вторичные конечные точки (5)

• detection rate [Срок оценки: within 28 days of MRI examination]
• Number of Participants with change of treatment plan from baseline [Срок оценки: within 28 days of MRI examination]
• Number of Participants with change of biopsy plan from baseline [Срок оценки: within 28 days of MRI examination]
• diagnostic accuracy of CESM [Срок оценки: within 28 days of MRI examination]
• difference by MRI and CESM [Срок оценки: within 28 days of MRI examination]

Критерии участия

Критерии включения

• 1\. Adult women aged 18-75 years old
• 2\. First-time referral to the breast clinic or inpatient department of the study center for being diagnosed as presenting with suspicious breast lesions by previous procedures in 30 days
• 3\. Presenting with Index lesions of "BI-RADS≥4" and additional findings in preoperative breast MRI
• 4\. Sign the informed consent form for this study.
• 5\. Commit to follow the research procedures and cooperate with the implementation of the whole process of the study.
• 6\. In the case of women of childbearing age, have been taken contraception for at least one month prior to screening and have had a negative serum or urine pregnancy test and commit to use contraception throughout the study period

Критерии исключения

• 1\. Patients with contraindications of intravenous administration of iodine contrast agent, such as pregnant or lactating women, patients with a history of iodine contrast agent allergy, patients with obvious hyperthyroidism
• 2\. It has been more than 14 days since the most recent preoperative breast MRI was performed for the relevant breast disease
• 3\. For the relevant breast disease, the preoperative breast MRI images and reports received within 14 days before screening are not available or do not meet the requirements of clinical diagnosis
• 4\. Patients who is receiving non-surgical interventional treatment such as neoadjuvant chemotherapy, hormone therapy or radiation therapy
• 5\. Patients who have received any breast operation for the relevant disease, such as various biopsies, therapeutic breast surgery
• 6\. Other patients assessed by the investigators as not suitable for the study, such as those who are difficult to cooperate with CESM examination due to unconsciousness, communication disorder or/and small breasts to meet the examination requirements

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

Китай · 1 центр

• Union Hospital of Tongji Medical College of Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT06475066 · UHCT230291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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