Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Correlate diffusion weight imaging MRI characteristics
研究概览
简要总结
This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.
详细描述
Primary Objective:
- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent
Secondary Objective:
- To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
- To assess the prognostic potential of MRI features
Correlative:
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
- 否
入选标准
- •Women and men at least 18 years of age.
- •Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
- •Hormone receptor negative (estrogen-receptor < 5% and/or progesterone-receptor < 5%)
- •Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
- •Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
- •Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
- •Have tissue available for additional correlative studies OR planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial
- •Be a candidate for MRI imaging.
- •Be willing to comply with scheduled visits required for the trial.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.
- •Poor visualization of the tumor on the initial breast MRI (investigator discretion)
- •Pregnant or nursing.
研究组 & 干预措施
Advanced Pathology
Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.
干预措施: Tempus assay (Other)
Advanced Pathology
Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.
干预措施: Advanced pathology 1 (Other)
Advanced Pathology
Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.
干预措施: Advanced pathology 2 (Other)
结局指标
主要结局
Correlate diffusion weight imaging MRI characteristics
时间窗: Baseline up to about 14 weeks
Correlate dynamic-contrast enhanced MRI characteristics
时间窗: Baseline up to about 14 weeks
次要结局
- Evaluate association between MRI features and pathologic response(Baseline up to about 14 weeks)
- Evaluate association between MRI features and recurrence-free survival(Baseline up to about 14 weeks)
研究者
Laura Kennedy
Sponsor Investigator
Vanderbilt-Ingram Cancer Center