Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality
研究概览
简要总结
*REFERRALS TO THIS TRIAL MUST BE THROUGH BREAST CARE CLINICIANS ONLY*
RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ.
PURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.
详细描述
OBJECTIVES:
- Compare the DCIS optimized MRI to the standard clinical MRI. Using a scale of 1-5 from poor to excellent, images will be assessed for conspicuity of DCIS and atypical ductal hyperplasia (ADH) lesions, agreement of disease extent with biopsy, and overall image quality (artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio).
- Subjects with ADH, a benign condition that can also show enhancement on MRI, will be enrolled to explore the utility of the DCIS optimized MRI for distinguishing DCIS and ADH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Breast Cancer patients
Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)
干预措施: Gadavist (Drug)
Breast Cancer patients
Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality
时间窗: 1 month
Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image quality for each MRI.
Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS
时间窗: 1 month
Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image variability for each MRI.
次要结局
未报告次要终点