iMagINg of Chemotherapy-Induced Morphological and Functional Lung Changes in Childhood Acute Lymphoblastic Leukemia and Hodgkin's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Morphologic lung assessment (LF-MRI)
研究概览
简要总结
With increasing cure rates of childhood cancer there is growing recognition of late effects of treatments. However, there is a lack of non-invasive and child-friendly procedures that can indicate possible late damage. This study uses morphologic and free-breathing phase-resolved functional low-field (PREFUL) magnetic resonance imaging (MRI) to identify persistent pulmonary toxicity after treatment for childhood acute lymphoblastic leukemia (ALL), Hodgkin's disease (HD) and allogeneic stem cell transplantation. Furthermore, cardiopulmonary testing is performed by means of a pulmonary function test, echocardiography with strain analysis and spiroergometry.
详细描述
With increasing cure rates of childhood cancer there is growing recognition of late effects of treatments. However, there is a lack of non-invasive and child-friendly procedures that can indicate possible late damage.
This study uses morphologic and free-breathing phase-resolved functional low-field (PREFUL) magnetic resonance imaging (MRI) to identify persistent pulmonary toxicity after treatment for childhood acute lymphoblastic leukemia (ALL), Hodgkin's disease (HD) and allogeneic stem cell transplantation. The examination in the new 0.55 T MRI system does not differ in procedure and especially with regard to contraindications for an MRI examination from an examination in routinely used 1.5 or 3T devices. There is no intravenous administration of contrast medium. This method has already yielded relevant results in a previous study on the frequency of lung parenchymal changes in pediatric and adolescent patients with past SARS-CoV-2 infection detected by PCR. In addition, study participants will undergo cardiopilmonary testing by spirometry, spiroergometry and echocardiography with strain analysis to assess cardiac and pulmonary performance. For the individual patient, the duration of study participation is 120 minutes. This includes approximately 30 minutes for education and consent of study participants/parents/guardians, 30 minutes for lung function test and MRI, and 30 minutes for cardiopulmonary testing.
The purpose of this study is to assess early posttherapeutic changes as well as possible persistent pulmonary toxicity and change in cardiopulmonary performance.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study arm: "Early therapeutic effects"
- •Inclusion Criteria:
- •Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
- •Completed induction therapy or radiotherapy
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, etc.)
- •Study arm: "Late therapeutic effects"
- •Inclusion Criteria:
- •Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
- •Completed intensive therapy or radiotherapy
- •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, etc.)
- •Study arm: "Effects of hematopoietic stem cell transplantation"
- •Inclusion Criteria:
- •Diagnosed acute lymphatic leukemia
- •Completed hematopoietic stem cell transplantation
- •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, etc.)
结局指标
主要结局
Morphologic lung assessment (LF-MRI)
时间窗: Single time point (1 day)
Morphologic changes in lung parenchyma
次要结局
- Cardiopulmonary testing (VE)(Single time point (1 day))
- Cardiopulmonary testing (O2-Pulse)(Single time point (1 day))
- Cardiopulmonary testing (RER)(Single time point (1 day))
- Cardiopulmonary testing (VT2)(Single time point (1 day))
- Functional lung assessment (LF-MRI)(Single time point (1 day))
- Cardiopulmonary testing (HRR)(Single time point (1 day))
- Cardiopulmonary testing (Borg-Scale)(Single time point (1 day))
- Cardiopulmonary testing (Strain-Analysis)(Single time point (1 day))
- Blood sample (Retention parameters)(Single time point (1 day))
- Cardiopulmonary testing (VO2max)(Single time point (1 day))
- Cardiopulmonary testing (VCO2)(Single time point (1 day))
- Cardiopulmonary testing (HR)(Single time point (1 day))
- Cardiopulmonary testing (BRR)(Single time point (1 day))
- Blood sample (Blood count)(Single time point (1 day))
- Blood sample (Enterocytes)(Single time point (1 day))
- Height(Single time point (1 day))
- Cardiopulmonary testing (Breath rate at VAT)(Single time point (1 day))
- Cardiopulmonary testing (HRV)(Single time point (1 day))
- Pulmonary test (Lung function)(Single time point (1 day))
- Blood sample (Liver enzymes)(Single time point (1 day))
- Weight(Single time point (1 day))
- Cardiopulmonary testing (VO2)(Single time point (1 day))