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临床试验/NCT02388230
NCT02388230已完成不适用

Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel

Institute of Cancer Research, United Kingdom1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年10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
16
试验地点
1
主要终点
Young's modulus (kPa) in the irradiated and non-irradiated breast.

研究概览

简要总结

Around 20% of women who receive breast radiotherapy (RT) experience moderate to severe breast hardening and shrinkage. These side-effects have been shown to be important factors influencing quality of life after breast radiotherapy. It is thought that the likelihood of developing these side-effects is related to the presence of underlying genetic differences in patients. In order to identify these genetic differences, the severity of side-effects needs to be accurately measured. Currently, clinical assessments are conducted by a clinician but this is not specific enough to be able to relate development of breast shrinkage and hardening to genetic differences. For example, clinical assessment often fails to distinguish between hardness due to swelling (known as oedema) and hardness due to generalised radiation-induced scarring (known as fibrosis). Ultrasound techniques, however, may be able to help quantify and characterise radiotherapy-associated changes in breast tissue allowing for better correlation with genetic abnormalities. Once genetic changes can be identified, adjustment of breast RT treatments (or add drugs) to help reduce side-effects in women at higher genetic risk of side-effects may be possible.

This study tests the ability of two forms of ultrasound, shear-wave elastography (USE) and ultrasound backscatter spectroscopy (UBS), to quantify and characterise breast shrinkage and firmness with a view to using these techniques to measure the late side-effects of breast RT to study the underlying causes of radiotherapy toxicity.

Principle research question: Can a new ultrasound technique (shear wave elastography) measure radiation-induced side-effects in women who have received breast radiotherapy?

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Two patient groups will be included:
  • IMPORT or FAST trial patients who received breast RT previously and have received four (or more) year follow-up assessment which found moderate or severe induration.
  • Patients who are (1) undergoing, or undergone recently, breast RT (general population) and have undergone a clinical assessment that found moderate or severe oedema, or (2) IMPORT HIGH patients who have received RT and have received one or two year follow-up which found moderate or severe oedema.

排除标准

  • Patients with bi-lateral breast cancer.
  • Patients who have undergone surgery to the contralateral breast for either benign or malignant conditions.

结局指标

主要结局

Young's modulus (kPa) in the irradiated and non-irradiated breast.

时间窗: Outcome measures will be assessed for each patient during their imaging appointment only. For group 1 patients imaging takes place more than 4 years post radiotherapy, for group 2 patients imaging takes place 3 months to 2 years post radiotherapy.

Difference in Young's Modulus measured in the irradiated breast and Young's Modulus measured in the non-irradiated breast in patients with reported breast hardness.

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
Sponsor

研究点 (1)

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