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)
9 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
180
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Axel Karow, PD. Dr. med.
- Número de telefone: 09131 8533118
- E-mail: axel.karow@uk-erlangen.de
Estude backup de contato
- Nome: Ferdinand Knieling, Prof. Dr. med.
- Número de telefone: 09131 8533118
- E-mail: ferdinand.knieling@uk-erlangen.de
Locais de estudo
-
-
-
Erlangen, Alemanha, 91054
- Recrutamento
- Department of Pediatrics and Adolescent Medicine
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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.
|
|
Outro: 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
|
|
Outro: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Morphological lung changes (MRI)
Prazo: Single time point
|
Morphological lung changes
|
Single time point
|
|
Functional lung parameters (MRI)
Prazo: Single time point
|
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
|
Single time point
|
|
Quantitative and functional cardiovascular changes (MRI)
Prazo: Single time point
|
Quantitative and functional cardiovascular changes of the heart
|
Single time point
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
DLCO
Prazo: Single time point
|
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
|
Single time point
|
|
VA
Prazo: Single time point
|
Alveolar Volume
|
Single time point
|
|
KCO
Prazo: Single time point
|
DLCO/VA (absolute and % of predicted value)
|
Single time point
|
|
VC
Prazo: single time point
|
VC (vital capacity) in %
|
single time point
|
|
FEV1
Prazo: Single time point
|
FEV1 (Forced Expiratory Volume in 1 Second) in %
|
Single time point
|
|
VO2
Prazo: Single time point
|
Oxygen uptake (VO2)
|
Single time point
|
|
VO2max
Prazo: Single time point
|
peak oxygen uptake (VO2max)
|
Single time point
|
|
RER
Prazo: Single time point
|
Respiratory exchange ratio (RER)
|
Single time point
|
|
VT2
Prazo: Single time point
|
Ventilatory anaerobic threshold (VT2)
|
Single time point
|
|
VCO2
Prazo: Single time point
|
Carbon dioxide output (VCO2)
|
Single time point
|
|
HR
Prazo: Single time point
|
Heart rate (HR)
|
Single time point
|
|
HRR
Prazo: Single time point
|
Heart Rate Reserve (HRR)
|
Single time point
|
|
Breath rate at VAT
Prazo: Single time point
|
Breath rate at VAT
|
Single time point
|
|
BRR
Prazo: Single time point
|
Breath rate reserve (BRR)
|
Single time point
|
|
VE
Prazo: Single time point
|
minute ventilation (VE)
|
Single time point
|
|
O2 Pulse
Prazo: Single time point
|
O2 Pulse
|
Single time point
|
|
HRV
Prazo: Single time point
|
Heart rate variability (HRV)
|
Single time point
|
|
Borg Scale
Prazo: Single time point
|
Exercise capacity (Borg Scale)
|
Single time point
|
|
Echocardiography
Prazo: Single time point
|
Myocardial function by echocardiographic strain and strain-rate imaging
|
Single time point
|
|
Clinical parameters 1
Prazo: Single time point
|
Age in years
|
Single time point
|
|
Clinical parameters 2
Prazo: Single time point
|
Gender
|
Single time point
|
|
Clinical parameters 3
Prazo: Single time point
|
Weight
|
Single time point
|
|
Clinical parameters 4
Prazo: Single time point
|
Ethnicity
|
Single time point
|
|
Clinical parameters 5
Prazo: Single time point
|
Time from therapy initiation/Interval until study day
|
Single time point
|
|
Clinical parameters 6
Prazo: Single time point
|
Current medication*
|
Single time point
|
|
Clinical parameters 7
Prazo: Single time point
|
Secondary diagnoses
|
Single time point
|
|
Blood pressure
Prazo: Single time point
|
Blood pressure measurement
|
Single time point
|
|
Clinical examination
Prazo: Single time point
|
Standard clinical examination
|
Single time point
|
|
Questionnaire regarding psychosocial aspects
Prazo: Single time point
|
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
|
Single time point
|
|
Blood samples 1
Prazo: Single time point
|
Presence of clonal hematopoiesis (CH)
|
Single time point
|
|
Blood samples 2
Prazo: Single time point
|
Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
|
Single time point
|
|
Blood samples 3
Prazo: Single time point
|
Clone size / variant allele frequency (VAF)
|
Single time point
|
|
Blood samples 4
Prazo: Single time point
|
Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
|
Single time point
|
|
Blood samples 5
Prazo: Single time point
|
Telomere biology parameters (e.g.
telomere length-related measures)
|
Single time point
|
|
Blood samples 6
Prazo: Single time point
|
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
|
Single time point
|
|
MSOT 1
Prazo: Single time point
|
Oxygenated haemoglobin (HbO₂)
|
Single time point
|
|
MSOT 2
Prazo: Single time point
|
Deoxygenated haemoglobin (HHb)
|
Single time point
|
|
MSOT 3
Prazo: Single time point
|
Total haemoglobin (tHb)
|
Single time point
|
|
MSOT 4
Prazo: Single time point
|
Tissue oxygen saturation (sO₂)
|
Single time point
|
|
MSOT 5
Prazo: Single time point
|
MSOT signal intensity per region of interest
|
Single time point
|
|
MSOT 6
Prazo: Single time point
|
MSOT topogram of perfusion of the m.
gastrocnemius
|
Single time point
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
14 de julho de 2026
Conclusão Primária (Estimado)
31 de maio de 2028
Conclusão do estudo (Estimado)
31 de outubro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
9 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de julho de 2026
Primeira postagem (Real)
15 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de julho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Doenças Linfáticas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Leucemia Linfóide
- Leucemia
- Doenças hemic e linfáticas
- Linfoma
- Leucemia-Linfoma Linfoblástico de Células Precursoras
- Técnicas de investigação
- Manipulação de amostras
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Perfurações
- Procedimentos cirúrgicos, operatórios
- Técnicas de diagnóstico, sistema respiratório
- Testes de função respiratória
- Coleção de amostras de sangue
- Espirometria
Outros números de identificação do estudo
- MaximALL
- DKS 2025.17 (Número de outro subsídio/financiamento: Deutsche Kinderkrebsstiftung)
- 2026-03 (Número de outro subsídio/financiamento: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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
Prazo de Compartilhamento de IPD
Beginning 9 months and ending 36 months following article publication
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .