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临床试验/NCT04050423
NCT04050423招募中不适用

Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2014年9月23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
1,200
试验地点
1
主要终点
Select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively

研究概览

简要总结

Our objective in this study is to identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize breast masses with high accuracy, as determined histopathologically. Breast cancer is the most frequent form of non-epithelial cancer diagnosed in women, with approximately 1.5 million new cases diagnosed annually worldwide. Accurate diagnosis and characterization of disease play an important role in therapy planning for breast cancer treatment. Currently, the gold standard method of tumour diagnosis is pathological examination of core biopsy specimens. However, the invasive core biopsies can cause post-surgical complications. Besides, some lesions require repeat biopsy due to sampling errors during the initial biopsy. Also X-ray mammography and ultrasound B-mode images, which are used by radiologists for breast examination, lack reliable information about micro-structural properties of tissues. There is an urgent need of a non-invasive imaging modality that can provide rapid and quantitative information for breast tumour characterization, in real time and at the patient bed. The main goal, as described above, is to select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively.

详细描述

This project is an observational/early validation study in human subjects that will use ultrasound imaging and spectroscopy to characterize suspected breast cancers. Patients will be imaged with ultrasound, and the acquired data will be analyzed using quantitative ultrasound techniques, in conjunction with textural analysis on generated parametric images. Results of quantitative ultrasound data analysis for these breast lumps will be compared to and correlated with their histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports, available from patient charts. From this data we will potentially estimate the best hybrid ultrasound-based biomarker that can characterize suspected breast cancers, noninvasively.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Women or men with suspected breast cancer
  • Patients should have the ability to understand and the willingness to sign a written Informed consent document.

排除标准

  • Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering in the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
  • Receiving any other investigational agents
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

结局指标

主要结局

Select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively

时间窗: Up to 5 years

Correlate quantitative ultrasound parameters obtained using spectroscopic techniques, in conjunction with textural analysis on generated parametric images, to the histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.

次要结局

  • Results of ultrasound-based breast cancer characterization and clinical outcomes.(Up to 5 years)

研究者

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

Dr. Gregory Czarnota

Radiation Oncologist and Clinician Scientist

Sunnybrook Health Sciences Centre

研究点 (1)

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