NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of using NearWave imaging as a monitoring system
研究概览
简要总结
The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).
详细描述
This is a prospective, observational, pilot study. Due to the investigational nature of the NearWave device, imaging data collected will not be used to inform patient treatment. Since this is our first experience with the NearWave device and there does not exist any preliminary data with this device, we are performing this pilot study to establish whether data collected is of high enough quality to warrant further study.
Primary Objective: The primary objective of this study is to assess the feasibility of using the NearWave optical molecular monitoring system during therapy to predict pCR in breast cancer patients undergoing NAC, measured by the data quality captured with the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Women ≥ 18 years old at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization
- •Patients who:
- •have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER/PR negative or low (ER and PR ≤ 9%, weak staining)
- •with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm
- •are planned to receive neoadjuvant chemotherapy followed by surgery
- •Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit
- •Have a palpable breast mass as determined by a treating physician
排除标准
- •Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
- •Inflammatory breast cancer
- •Prior breast cancer requiring surgery or radiation in either breast
- •Pregnant or nursing due to changes in breast architecture
- •Patients with a BMI of ≥ 40, unless the lesion is near the surface (<3 cm from the skin surface), based on diagnostic scan measurements
- •Patients with any tattoos on their breasts
研究组 & 干预措施
NearWave monitoring
Breast cancer patients receiving neoadjuvant chemotherapy treatment followed by surgery will be monitored by a noninvasive handheld imaging device before, during and after chemotherapy.
干预措施: NearWave monitoring (Device)
结局指标
主要结局
Feasibility of using NearWave imaging as a monitoring system
时间窗: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery
Adequate data quality metrics: Signal-to-noise ratio (SNR) (measurement that compares the strength of a signal to the level of background noise) above 10 dB for at least 80% of collected data points;
次要结局
未报告次要终点
研究者
Tarah J Ballinger, MD
Assistant Professor of Clinical Medicine
Indiana University