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临床试验/NCT05454553
NCT05454553招募中不适用

Efficacity of Deep Inspiration Breath Hold and Intensity-modulated Radiotherapy in Preventing PErfusion Defect for Left Sided Breast Cancer (EDIPE)

Institut de cancérologie Strasbourg Europe1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
58
试验地点
1
主要终点
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy

研究概览

简要总结

Breast irradiation is known to cause radiation-induced heart disease (RIHD) many years later after radiotherapy. Recent studies suggest that RIHD could be an earlier complication and that subclinical cardiac injury can be detected such as myocardial perfusion defects. Myocardial perfusion single photon emission computed tomography (SPECT) is a sensitive and specific technique able to detect perfusion abnormalities which are more frequent in left-sided breast cancer patients because of the cardiac exposure.

The most used technique for breast cancer irradiation is tangential opposed field, but this technique exposes the left anterior descending coronary artery to high dose during left breast irradiation.

There are different cardiac sparing techniques to reduce heart exposure such as:

  • Deep inspiration breath-hold (DIBH) which displaces the heart out of the radiation beam
  • Intensity-modulated radiation therapy (IMRT) which decreases heart exposure to high doses but changes the dose distribution in the heart and increases lower doses.

详细描述

In breast radiotherapy, especially for left sides breast cancers, the heart is the organ-at-risk which whose dose constraints are source of controversies. Historically breast cancer radiation therapy was associated with a significantly increased cardiac mortality. Two meta-analyses founded that the cardiac mortality risk was increased by 27% to 38%. This result is linked to outdated 2-D treatment techniques causing massive cardiac overexposure (Clarke M et al. 2005, Cheng YJ et al. 2017).

Three dimensional conformational radiotherapy reduced mean heart dose but the link between heart irradiation and radiation-induced heart damages doesn't seem to have threshold therefore to RHID is still a matter of concern (Darby SC et al. 2013; Taylor C et al. 2017).

The most used technique for breast cancer irradiation is opposite tangential field radiotherapy, however, it exposes the anterior interventricular coronary artery to a high dose during left breast irradiation (Nieder C et al. 2007). Therefore, radiotherapy techniques have developed to reduce cardiac exposure such as deep inspiration breath hold (DBIH) and intensity modulated radiation therapy (IMRT).

DBIH "mechanically" moves the heart away from the radiation beam and IMRT the dose distribution in the heart and reduces its exposure to high doses (Boda-Heggemann J et al. 2016, Lauche O et al. 2016).

Nevertheless, recent studies suggest that even with this level of cardiac exposure subclinical cardiac alterations may be detected, such as myocardial perfusion deficit (Eber et al. 2022; Marks LB et al. 2005; Gyenes G et al. 1997; Sioka C et al. 2011; Seddon B et al. 2002; Eftekhari M et al. 2015).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Patient with left sided breast cancer histologically confirmed after lumpectomy or mastectomy with/without lymph node involvement who are planned for DIBH-RT or IMRT
  • Age > 18 years
  • Karnofsky Performance Status (KPS) > 60%
  • Absence of psychiatric illness hindering follow-up
  • Patient understands French
  • Signature of informed consent
  • Patient registered with social security

排除标准

  • Bilateral breast cancer
  • History of thoracic irradiation
  • Pregnancy or breastfeeding
  • Any medical contraindication of cardiac SPECT or chest CT angiography.
  • Any medical contraindication of Regadenoson

结局指标

主要结局

Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy

时间窗: at 12 months from the end of radiotherapy

Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans

次要结局

  • Influence of cardiac risk factors on post-radiation myocardial perfusion.(up to 12 months from the end of radiotherapy)
  • Assessing the relevance of mean heart dose in the prevention of Radiation-induced heart disease (RIHD) compared to cardiac substructures.(up to 12 months from the end of radiotherapy)
  • Influence of anticancer therapy exposure on post-radiation myocardial perfusion(up to 12 months from the end of radiotherapy)
  • Assession of wall-motion abnormalities and left ventricular ejection fraction (LVEF) decrease(up to 12 months from the end of radiotherapy)
  • Impact of the location of the tumor bed boost on the cardiac dose.(up to 12 months from the end of radiotherapy)

研究者

发起方
Institut de cancérologie Strasbourg Europe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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