An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- pH measurement of the tumor will be measured by the CEST MRI.
研究概览
简要总结
Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.
详细描述
Those involved in the treatment of patients with breast cancer have pioneered the field of personalized cancer therapy through the use of targeted therapies and their associated biomarkers. Assays to quantify tumor acidosis and hypoxia are hypothesized to potentially represent such biomarkers. However there is currently no gold standard for measuring either.
This trial will evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe), to a clinical MRI scanner in women with early stage breast cancer. This trial will generate preliminary data regarding the feasibility of this imaging technique. If successful, in future studies CEST MRI may serve as an imaging biomarker for acidosis and hypoxia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast
- •>= 1.0 cm primary tumor
- •Calculated creatinine clearance >= 50 mL/min
- •Willing and able to provide informed consent
- •Age ≥ 18 years
- •ECOG performance status 0-2
- •Informed of the investigational nature of this study
排除标准
- •Allergy to iodinated contrast agent
- •Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs
- •Diabetes mellitus
- •History of severe claustrophobia
- •Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI
- •Use of > 1 antihypertensive drug
- •Pregnancy or breastfeeding
- •Paraproteinemia syndromes or multiple myeloma
- •Collagen vascular disease
- •Active hyperthyroidism
- •Active pharmaceutical treatments for cancer
研究组 & 干预措施
Optimization
CEST MRI of the breast for estimation of tumor pH.
干预措施: CEST MRI (Other)
结局指标
主要结局
pH measurement of the tumor will be measured by the CEST MRI.
时间窗: 2 weeks
pH estimate of the tumor
次要结局
- Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.(2 weeks)