BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean arterial TBRmax 18F FDG uptake
研究概览
简要总结
The advent of immunotherapy (immune checkpoint inhibitors [ICI]) has been an extremely important advancement for cancer treatment in recent decades. The anti-cancer effects of these agents is profound and can lead to radiological 'disappearance' of the primary cancer and metastatic deposits. ICI are now commonly used in the treatment of multiple cancers including melanoma, kidney cancer, liver cancer and lung cancer. ICI can be used on their own or in combination with other agents such as vascular endothelial growth factor inhibitors (VEGFi) which is first line treatment for many patients. However, it has become clear that these drugs have cardiovascular side effects including high blood pressure and a reduction in the heart muscle pumping function. It is also increasingly recognised that ICIs may have a toxic effect on blood vessels resulting in an increased risk of heart attack or stroke. These side effects can have a significant impact on patients' health and can lead to withdrawal of important cancer treatment. The mechanisms by which these side effects occur are unclear and have not been well described to date.
The aim of this study is to examine the effect of ICI and VEGFi, both alone and in combination, on blood vessels and to understand their effects on blood markers and heart function. This study is observational and will not require any modification of cancer therapy.
This study will aim to recruit patients diagnosed with cancer who are already planned to receive ICI or VEGFi alone or in combination at the Beatson West of Scotland Oncology Centre. Patients will undergo a vascular PET-CT scan before and 6 months after starting treatment. In addition patients will undergo echocardiography and tests of the function of the small blood vessels in the fingertips with a special machine (EndoPat). Blood and urine samples will also be collected.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cancer who are planned for treatment with ICI or VEGFI, including combination therapy
- •≥6 months predicted survival
- •Age ≥18 years
排除标准
- •Patients who are unable or unwilling to provide valid consent for the study
- •Patients with diabetes who are on oral anti-diabetic treatment or insulin at baseline
- •patients who have exposure to either immune checkpoint inhibitor or VEGF inhibitor in the 12 months before enrolment
结局指标
主要结局
Mean arterial TBRmax 18F FDG uptake
时间窗: 24 weeks
Inflammatory plaque activity (meanMaxTBR)\* in patients receiving ICI/VEGFI combination therapy versus ICI alone or VEGFI alone. \*Note \'meanMaxTBR\' is a PET measurement reflecting the average of the maximum \'target to background ratio \[TBR\]) where \'target\' denotes regions of PET radiotracer activity)
次要结局
- Blood and urine biomarker analysis(Baseline (pre-treatment) to 24 weeks)
- Inflammatory plaque activity (meanMaxTBR) in patients receiving ICI (alone or in combination) vs VEGFI alone.(Baseline (pre-treatment) to 24 weeks)
- PET activity with baseline cardiovascular risk factors and imaging (echo/CT)(Baseline (pre-treatment) to 24 weeks)
- The effect of ICI/VEGFI upon endothelial function (EndoPAT) will be examined.(Baseline (pre-treatment) to 24 weeks)
- PETCT 18F FDG uptake arterial analyses(Baseline (pre-treatment) to 24 weeks)