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临床试验/NCT04824027
NCT04824027招募中不适用

Predicting Response to Neoadjuvant Chemotherapy Using Harmonic Motion Imaging in Women With Breast Cancer

Columbia University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapy

研究概览

简要总结

For this study, the investigators propose investigation of a new imaging technique, Harmonic Motion Imaging (HMI), and the evaluation of its potential role in prediction of breast cancer response to neoadjuvant chemotherapy (NACT). The investigators hypothesize that changes in HMI parameters will predict response to neoadjuvant systemic therapy in early-stage breast cancer.

详细描述

Neoadjuvant chemotherapy (NACT) is the standard of care for treatment of locally advanced breast cancer (LABC) and inflammatory breast cancer, and is recently being used in earlier stage breast cancer. The ideal outcome of NACT is pathological complete response (pCR), which itself has shown to be associated with improved disease-free survival. However, pCR is currently determined at the time of the surgery when the patient has received the whole cycle of the treatment. Early detection of non-responders to NACT could be used to halt ineffective treatment and start a new chemotherapeutic regimen in order to achieve better tumor response and overall survival. Current techniques to monitor response to NACT based on tumor size changes include mammography, physical examination, ultrasonography and MRI. Clinically assessing tumor size has been shown to be only moderately useful for chemotherapy response prediction in these patients because tumor shrinkage is a late marker of effective treatment. Metabolic activities and microstructure changes induced by NACT can be determined using functional imaging methods such as PET-CT, contrast enhanced MRI and diffuse optical spectroscopy. However, the application of these methods is limited due to high cost and intravenous injection of exogenous contrast agents. Limited studies have shown the potential of ultrasound elastography to be useful in predicting and monitoring response to NACT in breast cancer tumors based on tumor stiffness. Harmonic Motion Imaging (HMI) is a novel ultrasound elastography technique that applies an oscillatory force locally and at different depths in the tissue, in order to determine the characteristics of the resulting localized harmonic motion using high precision tracking methods. Highly localized harmonic motion can be noninvasively generated by ultrasonic beams deep inside the tissue and estimated at high precision, by using RF signals and cross-correlation methods. In addition to not being burdened by the drawbacks encountered by existing techniques, due to the highly localized and harmonic nature of the response, the motion characteristics can be directly linked to the local tissue stiffness. In this study, the investigators propose to compare the changes in the measurements provided by HMI and pathological response rate, between baseline, during treatment and end of the treatment to assess whether HMI can early predict the tumor response to neoadjuvant therapy.

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

入选标准

  • Women age ≥18
  • Deemed eligible to receive neoadjuvant systemic therapy as per the treating physician, with the dose and schedule deemed appropriate by the treating physician.
  • Any stage invasive breast cancer provided the primary breast tumor size is ≥ 4 mm
  • Exclusion criteria:
  • Patient is pregnant or lactating
  • Presence of breast implants
  • History of laser or radiation therapy to the affected breast

排除标准

  • 未提供

结局指标

主要结局

Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapy

时间窗: Baseline and through neoadjuvant therapy completion (an average of 28 weeks)

* Repeated measures analysis of variance (ANOVA) will be performed to investigate the overall differences in HMI measurements within the tumor and surrounding tissue between responders (pCR and RCB1) and non-responders (RCB2). This relative percent change in tumor stiffness is directly related to HMI measurements. * Pathologic response will be assessed by the Residual Cancer Burden (RCB) score, a continuous and categorical measure of pathologic response and an independent predictor of disease free survival. Pathologic response will be dichotomized, with response defined as a score of 0-1 (RCB\<2), and no response defined as a score of 2-3 (RCB2).

Assessment of the correlation between change in HMI measurements and pathologic response during neoadjuvant systemic therapy

时间窗: Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation)

* Repeated measures analysis of variance (ANOVA) will be performed to investigate the overall differences in HMI measurements within the tumor and surrounding tissue between responders (pCR and RCB1) and non-responders (RCB2). This relative percent change in tumor stiffness is directly related to HMI measurements. * Pathologic response will be assessed by the Residual Cancer Burden (RCB) score, a continuous and categorical measure of pathologic response and an independent predictor of disease free survival. Pathologic response will be dichotomized, with response defined as a score of 0-1 (RCB\<2), and no response defined as a score of 2-3 (RCB2).

次要结局

  • Assessment of correlation between percent change of tumor size on breast ultrasound during treatment(Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation))
  • Assessment of correlation between percent change of tumor size on breast ultrasound and pathologic response at treatment completion(Baseline and through neoadjuvant therapy completion (an average of 28 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisa Konofagou

Robert and Margaret Hariri Professor in Biomedical Engineering and Radiology

Columbia University

研究点 (2)

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