Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
研究概览
简要总结
This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer.
SECONDARY OBJECTIVE:
I. To assess whether the accuracy of 3D SHAPE for predicting locally advanced breast cancer (LABC) NAC response varies with breast cancer subtype.
OUTLINE:
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •At least 21 years old
- •Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)
- •Be scheduled for neoadjuvant chemotherapy
- •Be medically stable
- •Be conscious and able to comply with study procedures
- •If a female of child-bearing potential, must have a negative urine pregnancy test
排除标准
- •Females who are pregnant or nursing
- •Patients with other primary cancers requiring systemic treatment
- •Patients with any distal metastatic disease
- •Patients undergoing neoadjuvant endocrine therapy
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- •Patients on life support or in a critical care unit;
- •Patients with unstable occlusive disease (e.g., crescendo angina);
- •Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia;
- •Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] Class IV);
- •Patients with recent cerebral hemorrhage;
- •Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- •Patients with known hypersensitivity or allergy to any component of Definity
- •Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
- •Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
研究组 & 干预措施
Diagnostic (CEUS, Definity)
Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC
干预措施: Contrast-Enhanced Ultrasound (Procedure)
Diagnostic (CEUS, Definity)
Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC
干预措施: Ultrasound (Procedure)
Diagnostic (CEUS, Definity)
Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC
干预措施: Perflutren Lipid Microspheres (Drug)
结局指标
主要结局
Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
时间窗: Up to study completion (48 months)
3-dimensional (3D) tumor measurements over the three ultrasound exams will be recorded for each subject to calculate tumor volume changes with NAC. The tumor volume change during the therapy will be compared to imaging (magnetic resonance imaging or ultrasound) and pathologic response as well as to the corresponding 3D subharmonic aided pressure estimation (SHAPE) results.
The ability of the SHAPE method to distinguish responders from non-responders
时间窗: Up to study completion (48 months)
Will also be compared using receiver operating characteristic analysis to develop thresholds for decision-making based on balancing sensitivity and specificity.
Prediction of the patients' clinical and pathological response
时间窗: Up to study completion (48 months)
The SHAPE results from three time points (i.e. before, 10% completion, and 30% completion of NAC) will be modeled for predicting the patients' clinical response as well as pathological response using longitudinal logistic regression with adjustment for correlated observations over time by generalized linear mixed effects or generalized estimating equations (GEE) modeling.
次要结局
- Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype(Up to study completion (48 months))
研究者
Kibo Nam
Principal Investigator
Thomas Jefferson University