Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Tumor infiltrating lymphocytes (TILs)
研究概览
简要总结
This is a single institution, observational research study in which patients are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.
详细描述
This is not a treatment trial. Patients will be treated according to the plan developed by their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of planned systemic therapy will be eligible for this imaging study. Patients and their referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery and after the pre-therapy 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
- 否
入选标准
- •Subjects at least 18 years of age.
- •Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive.
- •Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2 agent.
- •Have tissue block available for review of experimental markers.
- •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
- •Recent therapy for breast cancer prior to baseline MRI.
- •Subjects may not receive other investigational agents during the study window for imaging.
- •Contraindications for MRI or MRI contrast including severe claustrophobia, history of previous reaction to MRI contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or bullet.
- •Pregnant or nursing.
结局指标
主要结局
Tumor infiltrating lymphocytes (TILs)
时间窗: 10 years
Determine whether early changes on MRI reflect the level of immune response (based on TILs) in the tumor as measured by histologic assessment after 1 cycle of anti-HER2 treatment
次要结局
未报告次要终点
研究者
Savannah Partridge
Professor
University of Washington