"MaximALL" More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Morphological lung changes (MRI)
研究概览
简要总结
In this study, we investigate the cardiopulmonary health of survivors who underwent cancer treatment for acute lymphoblastic leukemia (ALL) or lymphoma during childhood, compared with healthy controls. Modern imaging techniques (MRI, MSOT, and echocardiography) as well as questionnaires assessing cardiopulmonary and mental health are used.
详细描述
Survivors of childhood cancer have a high risk of developing late effects regarding different organ systems even years after treatment. Our preliminary data show that a high number of our study participants who have received oncological treatment for ALL or Hodgkin's disease, develop severe ventilation and/or perfusion disorders/defects that can be detected on MRI of the lungs. These changes are mainly observed in participants with a greater interval to the oncological treatment and we could find a significant correlation between ventilation- and perfusion defects and the timespan after diagnosis. In spiroergometry, our patient group showed reduced aerobic capacity (ViO2 max), regardless of the time of follow-up. Echocardiography including strain analysis resulted in suspicious findings. The aim of our follow-up project is to validate these results in a larger patient population and to extend the investigations of long-term follow up after oncological disease/treatment in childhood and adolescence. We are planning to conduct a multicenter study with participants (who received oncological treatment in childhood or adolescence and are now undergoing long-term-follow-up care (> 5 years after treatment,). Therefore, we will examine morphological und functional lung changes by low field strength MRI and spiroergometry. We plan to investigate cardiac changes by echocardiography with strain analysis and ECG. Additionally, we would like to use multispectral optoacoustic tomography (MSOT) screening for muscle atrophy due to peripheral artery disease (PAD) as another modern imaging procedure for early detection of vascular changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control Group:
- •Inclusion Criteria:
- •no cancer diagnosis
- •no lung diseases
- •no vascular diseases
- •No subjective reduction in physical performance
- •age >/= 18 years
排除标准
- •Pregnancy, Lactation
- •Known pleural or pericardial effusion
- •Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- •Marked thoracic deformities/malformations
- •Previous lung surgery
- •Injuries that do not allow physical stress diagnostics
- •Rejection of MRI imaging
- •General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
- •Survivors of ALL:
- •Inclusion Criteria:
- •Completed therapy for ALL
- •age >/= 3 years
- •Exclusion Criteria:
- •Pregnancy, Lactation
- •Known pleural or pericardial effusion
- •Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- •Marked thoracic deformities/malformations
- •Previous lung surgery
- •Injuries that do not allow physical stress diagnostics
- •Rejection of MRI imaging
- •General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
- •Survivors of Lymphoma:
- •Inclusion Criteria:
- •Completed therapy for lymphoma
- •age >/= 3 years
- •Exclusion Criteria:
- •Pregnancy, Lactation
- •Known pleural or pericardial effusion
- •Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- •Marked thoracic deformities/malformations
- •Previous lung surgery
- •Injuries that do not allow physical stress diagnostics
- •Rejection of MRI imaging
- •General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
结局指标
主要结局
Morphological lung changes (MRI)
时间窗: Single time point
Morphological lung changes
Functional lung parameters (MRI)
时间窗: Single time point
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
Quantitative and functional cardiovascular changes (MRI)
时间窗: Single time point
Quantitative and functional cardiovascular changes of the heart
次要结局
- VO2max(Single time point)
- VE(Single time point)
- O2 Pulse(Single time point)
- HRV(Single time point)
- RER(Single time point)
- VT2(Single time point)
- VCO2(Single time point)
- HR(Single time point)
- HRR(Single time point)
- Breath rate at VAT(Single time point)
- BRR(Single time point)
- Borg Scale(Single time point)
- Blood pressure(Single time point)
- Clinical parameters 6(Single time point)
- Clinical parameters 7(Single time point)
- MSOT 6(Single time point)
- Clinical examination(Single time point)
- VO2(Single time point)
- DLCO(Single time point)
- VA(Single time point)
- KCO(Single time point)
- VC(single time point)
- FEV1(Single time point)
- Echocardiography(Single time point)
- Clinical parameters 1(Single time point)
- Clinical parameters 2(Single time point)
- Clinical parameters 3(Single time point)
- Clinical parameters 4(Single time point)
- Clinical parameters 5(Single time point)
- Questionnaire regarding psychosocial aspects(Single time point)
- Blood samples 1(Single time point)
- Blood samples 2(Single time point)
- Blood samples 3(Single time point)
- Blood samples 4(Single time point)
- Blood samples 5(Single time point)
- Blood samples 6(Single time point)
- MSOT 1(Single time point)
- MSOT 2(Single time point)
- MSOT 3(Single time point)
- MSOT 4(Single time point)
- MSOT 5(Single time point)
研究者
Ferdinand Knieling
Prof. Dr. med. Dr. rer. biol. hum. Ferdinand Knieling MHBA
University of Erlangen-Nürnberg Medical School
