跳至主要内容
临床试验/NCT02688257
NCT02688257已完成不适用

Assessing Treatment Response of Breast Cancer Using Multimodal Functional Imaging

Institute of Cancer Research, United Kingdom1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
Early and late changes of oxygenation and residual cellularity of patients treated with neoadjuvant chemotherapy, measured using the blood oxygen level dependent (BOLD) technique.

研究概览

简要总结

Patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. Newer techniques such as functional MRI, microbubble and optoacoustic ultrasound offer the potential to detect responses to chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither modality utilises ionising radiation.

Although MRI is widely used for detecting breast cancer, its ability in assessing functional responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of blood volume and flow. Other functional techniques detect variation in tissue oxygenation: this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a special magnetic resonance (MR) sequence called T2* to measure the weakly magnetic effect of deoxygenated haemoglobin. The investigators wish to develop and validate T2* measurements which relate to oxygenation of a tumour. The investigators also want to validate other MR sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood in the capillary network and the diffusion of water within tissues.

Microbubble ultrasound is an established technique that utilises an intravenous contrast agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and enhance spectral and colour Doppler signals obtained from routine ultrasound imaging. Optoacoustic imaging is new technique where the output signal depends on the oxygenation of the tissues under study. It utilises a light signal input and measures ultrasound signal output.

The investigators want to correlate our imaging findings with histopathology after surgical resection of the tumour.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with breast cancer due for neoadjuvant chemotherapy

排除标准

  • Ferromagnetic implants within body in accordance with standard clinical practice
  • claustrophobia
  • age <18 or >90

结局指标

主要结局

Early and late changes of oxygenation and residual cellularity of patients treated with neoadjuvant chemotherapy, measured using the blood oxygen level dependent (BOLD) technique.

时间窗: 6 years

The primary aim of the study is to determine whether specific MRI sequences including dynamic contrast enhanced (DCE) MRI, T2\*, diffusion weighted (DW) MRI, as well as microbubble and optoacoustic ultrasound imaging provide early measures of treatment response in breast tumours treated with neoadjuvant chemotherapy.

次要结局

未报告次要终点

研究者

发起方
Institute of Cancer Research, United Kingdom
申办方类型
Other
责任方
Principal Investigator
主要研究者

NdeSouza

Professor Nandita DeSouza

Institute of Cancer Research, United Kingdom

研究点 (1)

Loading locations...

相似试验