NCT03709186已完成不适用
Radiomic Markers for Breast Cancer Metastasis Using Dynamic Contrast Enhanced MRI and Diffusion-Weighted MRI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR)
研究概览
简要总结
The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.
详细描述
The study aims to evaluate radiomic markers in breast tumors to evaluate metastatic risk based on radiomic features following primary therapy. The investigators aim to analyze images at various time intervals before, during and after primary treatments using two advanced imaging techniques (DCE-MRI & DWI-MRI).
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
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must give appropriate written informed consent prior to participation in the study;
- •Subjects must be able and willing to comply with the safety procedures during the scanning period;
- •Subjects must be men and women age 18+
- •Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-).
- •Stage I-III disease according to the AJCC v7 criteria.
- •Patients with sufficient renal function (creatinine clearance, i.e., >=30 mL/min/1.73 m2).
- •Primary treatments can include neoadjuvant chemotherapy or surgery
排除标准
- •Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue.
- •Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast
- •Subjects with a current or past medical history of connective tissue disease
- •Subjects who are pregnant or lactating
- •Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator
- •Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.
- •Allergies to any contrast agent administered to this study.
结局指标
主要结局
Pathologic complete response (pCR)
时间窗: Up to 60 months
Evaluating the degree of absence of residual cancer cells
次要结局
- Time to distant metastasis(Up to 60 months)
- Time to death(Up to 60 months)
- Time to distant breast cancer recurrence (months)(Up to 60 months)
研究者
Dr. William Tran
Radiation Therapist Clinician Scientist
Sunnybrook Health Sciences Centre
研究点 (1)
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