Contrast-Enhanced Mammography or Breast MRI: Which Choice for Optimal Diagnostic Performance?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of CEM vs. MRI for Breast Lesion Detection and Characterization
研究概览
简要总结
This study compares the diagnostic performance of Contrast-Enhanced Mammography (CEM) and Breast MRI in evaluating breast lesions. It aims to assess sensitivity, specificity, and diagnostic accuracy to identify the optimal imaging modality for clinical scenarios such as dense breast tissue and high-risk populations.
详细描述
Search differences and performance of MRI and CEM
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: Women aged 18 years and older.
- •Indication for Advanced Imaging: Patients referred for Contrast-Enhanced Mammography (CEM) or Breast MRI due to suspicious findings or high-risk factors for breast cancer.
- •Dense Breast Tissue or Inconclusive Findings: Patients with dense breast tissue or inconclusive results from standard mammography.
- •Informed Consent: Ability to provide written informed consent for participation in the study.
- •Presence of Breast Tissue: Female or transgender women who have breast tissue suitable for imaging.
排除标准
- •Contraindications to MRI: Patients with contraindications to Breast MRI (e.g., implanted pacemakers, severe claustrophobia, or metallic implants that cannot be removed).
- •Contraindications to Contrast Agents: Patients who have allergies or contraindications to iodinated contrast agents used in CEM.
- •Severe Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²), as they may not safely undergo contrast-enhanced imaging.
- •Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding, as the use of contrast agents may pose risks to the fetus or infant.
- •Already Confirmed Primary Tumor: Patients with a confirmed primary breast malignancy or another primary tumor site (e.g., gastrointestinal, lung) that has already been diagnosed.
- •Other Medical Conditions: Patients with serious medical conditions that may interfere with participation in the study or may affect the safety of the imaging procedures.
结局指标
主要结局
Diagnostic Accuracy of CEM vs. MRI for Breast Lesion Detection and Characterization
时间窗: From enrollment to the end of treatment at 12 months
The primary outcome of the study is to compare the diagnostic accuracy of Contrast-Enhanced Mammography (CEM) and Breast Magnetic Resonance Imaging (MRI) in detecting and characterizing breast lesions. This will be assessed by evaluating the sensitivity, specificity, and overall diagnostic performance of both imaging modalities. Findings will be correlated with histopathological results or follow-up imaging to determine the accuracy of each modality in the diagnosis of breast cancer.
次要结局
- Sensitivity and Specificity of CEM vs. MRI(From enrollment to the end of treatment at 12 months)
- Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of CEM vs. MRI(From enrollment to the end of treatment at 12 months)
- Patient Preference and Tolerability of CEM vs. MRI(From enrollment to the end of treatment at 12 months)
研究者
Graziella di Grezia
principal investigator
Link Campus University