ACTRN12615001238561已完成未知
To determine the feasibility of cardiac MRI, echocardiography and serum biomarkers in detecting both early and later cardiac dysfunction in cancer patients after exposure to chemotherapy and/or radiotherapy.
iverpool Hospital0 个研究点目标入组 44 人开始时间: 2015年11月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Cohort A – breast cancer patients
- •(i) Aged greater than or equal to 18 years or older
- •(ii) Histologically confirmed diagnosis of invasive breast carcinoma
- •(iii) Receiving any anthracycline-containing breast cancer treatment regimen, including any adjuvant trastuzumab therapy AND going on to receive adjuvant left breast +/- loco-regional nodal radiotherapy, OR
- •(iv) Receiving adjuvant left breast +/- loco-regional nodal radiotherapy alone (without chemotherapy).
- •Acceptable radiotherapy regimens for Cohort A patients include:
- •a)50Gy in 25 daily fractions +/- 10-16Gy tumour bed boost, over 5-6 weeks
- •b)42.4Gy in 16 daily fractions +/- 10Gy tumour bed boost, over 3-4 weeks
- •Cohort B – Non Hodgkin (NHL) Hodgkin lymphoma (HL) and leukaemia patients
- •(i) Aged greater than or equal to 18 years or older
- •(ii) Histologically confirmed diagnosis of lymphoma
- •(iii) Receiving any anthracycline-or alkylator-containing chemotherapy regimen (eg. R-CHOP for NHL patients and ABVD for HL patients) and/or
- •(iv) Receiving definitive or adjuvant (post-chemotherapy) radiotherapy (dose greater than or equal to 20Gy) encompassing the mediastinum (ie. including cardiac structures)
- •Acceptable radiotherapy regimens for Cohort B patients include:
- •*Dose ranges from 20-40Gy in 1.5-2Gy daily fractions, over 2-4 weeks
- •Cohort C – other intra-thoracic/upper gastrointestinal malignancy patients (eg oesophageal/other eg thymoma)
- •(i) Aged greater than or equal to 18 years or older
- •(ii) Histologically confirmed intra-thoracic or upper gastrointestinal malignancy
- •(iii)Receiving any neoadjuvant - and/or adjuvant or concurrent chemotherapy regimen and
- •(iv)Receiving definitive or adjuvant radiotherapy (dose greater than or equal to 20Gy) encompassing the mediastinum (ie including cardiac structures)
排除标准
- •(i) any contraindication to cardiac MRI (i.e. shrapnel, metallic implants/clips, pacemaker or defibrillator);
- •(ii) severe claustrophobia;
- •(iii) an estimated glomerular filtration rate of less than 50 mL/min/1.732;
- •(iv) pregnancy or breast feeding;
- •(v) documented distant metastases from their known primary cancer;
- •(vi) patients receiving cancer treatment with palliative intent
- •(vii) planned or current use of other targeted biological therapies that can potentially cause cardiotoxicity (i.e. lapatinib)
- •(viii) Pre-existing symptomatic Heart Failure (NYHA Class III or IV).
- •(ix) Recent acute coronary syndrome (myocardial infarction, unstable angina) within the last six months
- •(x) Recent coronary revascularization (percutaneous coronary intervention or coronary bypass surgery) within six months
- •(xi) Permanent atrial fibrillation
- •(xii) Prosthetic breast implants that preclude echocardiography examination
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