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) (MaximALL)
2026年7月9日 更新者：Ferdinand Knieling、University of Erlangen-Nürnberg Medical School
"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)
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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
180
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Axel Karow, PD. Dr. med.
- 电话号码：09131 8533118
- 邮箱：axel.karow@uk-erlangen.de
研究联系人备份
- 姓名：Ferdinand Knieling, Prof. Dr. med.
- 电话号码：09131 8533118
- 邮箱：ferdinand.knieling@uk-erlangen.de
学习地点
-
-
-
Erlangen、德国、91054
- 招聘中
- Department of Pediatrics and Adolescent Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
描述
Control Group:
Inclusion Criteria:
- no cancer diagnosis
- no lung diseases
- no vascular diseases
- No subjective reduction in physical performance
- age >/= 18 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 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.)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Control Group
Healthy individuals with no previous cancer diagnosis.
Volunteers will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) is performed.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
|
|
其他：Survivors of leukemia
Survivors of treatment for acute lymphatic leukemia in childhood or adolescence.
Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed.
compliant data storage).
In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
QoL assessment by EORTC SURV100, PPR
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
|
|
其他：Survivors of lymphoma
Survivors of treatment for lymphoma in childhood or adolescence.
Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed.
compliant data storage).
In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
QoL assessment by EORTC SURV100, PPR
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Morphological lung changes (MRI)
大体时间：Single time point
|
Morphological lung changes
|
Single time point
|
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Functional lung parameters (MRI)
大体时间：Single time point
|
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
|
Single time point
|
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Quantitative and functional cardiovascular changes (MRI)
大体时间：Single time point
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Quantitative and functional cardiovascular changes of the heart
|
Single time point
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
DLCO
大体时间：Single time point
|
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
|
Single time point
|
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VA
大体时间：Single time point
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Alveolar Volume
|
Single time point
|
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KCO
大体时间：Single time point
|
DLCO/VA (absolute and % of predicted value)
|
Single time point
|
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VC
大体时间：single time point
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VC (vital capacity) in %
|
single time point
|
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FEV1
大体时间：Single time point
|
FEV1 (Forced Expiratory Volume in 1 Second) in %
|
Single time point
|
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VO2
大体时间：Single time point
|
Oxygen uptake (VO2)
|
Single time point
|
|
VO2max
大体时间：Single time point
|
peak oxygen uptake (VO2max)
|
Single time point
|
|
RER
大体时间：Single time point
|
Respiratory exchange ratio (RER)
|
Single time point
|
|
VT2
大体时间：Single time point
|
Ventilatory anaerobic threshold (VT2)
|
Single time point
|
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VCO2
大体时间：Single time point
|
Carbon dioxide output (VCO2)
|
Single time point
|
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HR
大体时间：Single time point
|
Heart rate (HR)
|
Single time point
|
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HRR
大体时间：Single time point
|
Heart Rate Reserve (HRR)
|
Single time point
|
|
Breath rate at VAT
大体时间：Single time point
|
Breath rate at VAT
|
Single time point
|
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BRR
大体时间：Single time point
|
Breath rate reserve (BRR)
|
Single time point
|
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VE
大体时间：Single time point
|
minute ventilation (VE)
|
Single time point
|
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O2 Pulse
大体时间：Single time point
|
O2 Pulse
|
Single time point
|
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HRV
大体时间：Single time point
|
Heart rate variability (HRV)
|
Single time point
|
|
Borg Scale
大体时间：Single time point
|
Exercise capacity (Borg Scale)
|
Single time point
|
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Echocardiography
大体时间：Single time point
|
Myocardial function by echocardiographic strain and strain-rate imaging
|
Single time point
|
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Clinical parameters 1
大体时间：Single time point
|
Age in years
|
Single time point
|
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Clinical parameters 2
大体时间：Single time point
|
Gender
|
Single time point
|
|
Clinical parameters 3
大体时间：Single time point
|
Weight
|
Single time point
|
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Clinical parameters 4
大体时间：Single time point
|
Ethnicity
|
Single time point
|
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Clinical parameters 5
大体时间：Single time point
|
Time from therapy initiation/Interval until study day
|
Single time point
|
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Clinical parameters 6
大体时间：Single time point
|
Current medication*
|
Single time point
|
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Clinical parameters 7
大体时间：Single time point
|
Secondary diagnoses
|
Single time point
|
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Blood pressure
大体时间：Single time point
|
Blood pressure measurement
|
Single time point
|
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Clinical examination
大体时间：Single time point
|
Standard clinical examination
|
Single time point
|
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Questionnaire regarding psychosocial aspects
大体时间：Single time point
|
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
|
Single time point
|
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Blood samples 1
大体时间：Single time point
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Presence of clonal hematopoiesis (CH)
|
Single time point
|
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Blood samples 2
大体时间：Single time point
|
Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
|
Single time point
|
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Blood samples 3
大体时间：Single time point
|
Clone size / variant allele frequency (VAF)
|
Single time point
|
|
Blood samples 4
大体时间：Single time point
|
Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
|
Single time point
|
|
Blood samples 5
大体时间：Single time point
|
Telomere biology parameters (e.g.
telomere length-related measures)
|
Single time point
|
|
Blood samples 6
大体时间：Single time point
|
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
|
Single time point
|
|
MSOT 1
大体时间：Single time point
|
Oxygenated haemoglobin (HbO₂)
|
Single time point
|
|
MSOT 2
大体时间：Single time point
|
Deoxygenated haemoglobin (HHb)
|
Single time point
|
|
MSOT 3
大体时间：Single time point
|
Total haemoglobin (tHb)
|
Single time point
|
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MSOT 4
大体时间：Single time point
|
Tissue oxygen saturation (sO₂)
|
Single time point
|
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MSOT 5
大体时间：Single time point
|
MSOT signal intensity per region of interest
|
Single time point
|
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MSOT 6
大体时间：Single time point
|
MSOT topogram of perfusion of the m.
gastrocnemius
|
Single time point
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月14日
初级完成 (估计的)
2028年5月31日
研究完成 (估计的)
2028年10月31日
研究注册日期
首次提交
2026年7月9日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月15日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MaximALL
- DKS 2025.17 (其他赠款/资助编号：Deutsche Kinderkrebsstiftung)
- 2026-03 (其他赠款/资助编号：Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The raw, individual and identifiable patient data are protected and are not available due to data privacy laws.
Further data sets are planned to be shared
IPD 共享时间框架
Beginning 9 months and ending 36 months following article publication
IPD 共享访问标准
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:
Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication.
The data will be available to researchers who provide a methodologically sound proposal.
The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de.
Restrictions may apply due to patient privacy and the General Data Protection Regulation.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.