Optical Monitoring of Neoadjuvant Chemotherapy and Prediction of Pathological Complete Response in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Optical monitoring of neoadjuvant chemotherapy in breast cancer patients
研究概览
简要总结
Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Tumor response may vary among different BC subtypes and only 30% of BC respond completely to NAC. Treating chemo-resistant disease with NAC may cause patient harm due to drug toxicity and surgery delay.
It is therefore very important to promptly identify those women who will not benefit from NAC.
Mammography and ultrasound proved ineffective in monitoring changes in lesion size due to therapy-induced fibrosis. MRI is the most accurate imaging technique for assessing early clinical response by measuring tumor size, however its accuracy is lower post NAC. This necessitates the need for a new technique able to non invasively assess the effectiveness of NAC. Optical techniques are sensitive to the biological changes that occur within the tumor after NAC administration. These changes occur prior to tumor size reduction.
Optically estimated total hemoglobin concentration correlates with the histological analysis of vasculature as well as with tumor-associated angiogenesis which can affect tumor changes during NAC. Other promising biomarkers related to tissue composition (water, lipid, collagen content) and structure (scattering) may also be evaluated by optical techniques.
The aim of the study is to monitor the effectiveness of NAC in BC patients with a near infrared spectroscopic imaging platform which allows to non-invasively detect changes in vascularization and size of BC and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers (oxy- and deoxyhemoglobin, water, lipid and collagen concentration, scattering) within tissue during NAC.
This optical imaging technique will provide a non-invasive, safe and relatively inexpensive tool to monitor patients' response to NAC and to predict their outcome.
详细描述
In this study, an accurate, reliable, non-invasive modality with good patient tolerance will be tested to predict response to NAC in order to tailor the medical and surgical treatment.
The aim of this project is to monitor the effectiveness of NAC in BC patients with a new near infrared spectroscopic imaging platform which allows to non-invasively detect changes in size, vascularization and blood oxygenation in tumors and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers like oxy- and deoxyhemoglobin, water, lipid and collagen and scattering in the tissue during NAC. This optical imaging tool will allow a non-invasive, safe and relatively inexpensive monitoring of NAC and prediction of patients' outcome.
A single-site, national, non-comparative, non-randomized study will be conducted at the San Raffaele Hospital in Milan in collaboration with the Politecnico di Milano. The medical device is a prototype developed by Politecnico di Milano.
Twenty adult women with a recent diagnosis of breast cancer and candidate for NAC, who fulfil the inclusion criteria and agree to voluntary participate in the study under informed consent, will be enrolled.
Besides assessing the response to neoadjuvant chemotherapy using conventional imaging evaluation (x-ray mammography and breast ultrasound prior to commencement/baseline, half way through and on completion of NAC; contrast-enhanced MRI prior to commencement/baseline and on completion of NAC), the patients enrolled will be evaluated with optical imaging at the following six selected time points (prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women above 18 years of age
- •Women with a recent diagnosis of breast cancer candidate for neoadjuvant chemotherapy
- •Women willing to give informed consent
排除标准
- •Subject is pregnant or breastfeeding
- •Subject is unable or unwilling to give informed consent
- •Previous surgery of the same breast
- •Presence of distant metastasis
- •Breast implants
结局指标
主要结局
Optical monitoring of neoadjuvant chemotherapy in breast cancer patients
时间窗: The through completion study is that of an average of 1 year
Optical data will be compared to the conventional imaging results and to the surgical specimen histology (gold standard)
Prediction of pathological complete response to neoadjuvant chemotherapy using optical imaging
时间窗: The through completion study is that of an average of 1 year
Optical data will be evaluated to distinguish responders from non responders
次要结局
未报告次要终点
研究者
Pietro Panizza
Head of Breast Imaging Unit, MD
IRCCS San Raffaele