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 julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Axel Karow, PD. Dr. med.
- Número de teléfono: 09131 8533118
- Correo electrónico: axel.karow@uk-erlangen.de
Copia de seguridad de contactos de estudio
- Nombre: Ferdinand Knieling, Prof. Dr. med.
- Número de teléfono: 09131 8533118
- Correo electrónico: ferdinand.knieling@uk-erlangen.de
Ubicaciones de estudio
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Erlangen, Alemania, 91054
- Reclutamiento
- Department of Pediatrics and Adolescent Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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.
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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.
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Otro: 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
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Otro: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Morphological lung changes (MRI)
Periodo de tiempo: Single time point
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Morphological lung changes
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Single time point
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Functional lung parameters (MRI)
Periodo de tiempo: Single time point
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Ventilation match/mismatch, Perfusion match/mismatch, combined defects
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Single time point
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Quantitative and functional cardiovascular changes (MRI)
Periodo de tiempo: Single time point
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Quantitative and functional cardiovascular changes of the heart
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Single time point
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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DLCO
Periodo de tiempo: Single time point
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diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
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Single time point
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VA
Periodo de tiempo: Single time point
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Alveolar Volume
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Single time point
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KCO
Periodo de tiempo: Single time point
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DLCO/VA (absolute and % of predicted value)
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Single time point
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VC
Periodo de tiempo: single time point
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VC (vital capacity) in %
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single time point
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FEV1
Periodo de tiempo: Single time point
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FEV1 (Forced Expiratory Volume in 1 Second) in %
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Single time point
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VO2
Periodo de tiempo: Single time point
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Oxygen uptake (VO2)
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Single time point
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VO2max
Periodo de tiempo: Single time point
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peak oxygen uptake (VO2max)
|
Single time point
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RER
Periodo de tiempo: Single time point
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Respiratory exchange ratio (RER)
|
Single time point
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VT2
Periodo de tiempo: Single time point
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Ventilatory anaerobic threshold (VT2)
|
Single time point
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VCO2
Periodo de tiempo: Single time point
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Carbon dioxide output (VCO2)
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Single time point
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HR
Periodo de tiempo: Single time point
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Heart rate (HR)
|
Single time point
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HRR
Periodo de tiempo: Single time point
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Heart Rate Reserve (HRR)
|
Single time point
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Breath rate at VAT
Periodo de tiempo: Single time point
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Breath rate at VAT
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Single time point
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BRR
Periodo de tiempo: Single time point
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Breath rate reserve (BRR)
|
Single time point
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VE
Periodo de tiempo: Single time point
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minute ventilation (VE)
|
Single time point
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O2 Pulse
Periodo de tiempo: Single time point
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O2 Pulse
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Single time point
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HRV
Periodo de tiempo: Single time point
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Heart rate variability (HRV)
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Single time point
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Borg Scale
Periodo de tiempo: Single time point
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Exercise capacity (Borg Scale)
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Single time point
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Echocardiography
Periodo de tiempo: Single time point
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Myocardial function by echocardiographic strain and strain-rate imaging
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Single time point
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Clinical parameters 1
Periodo de tiempo: Single time point
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Age in years
|
Single time point
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Clinical parameters 2
Periodo de tiempo: Single time point
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Gender
|
Single time point
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Clinical parameters 3
Periodo de tiempo: Single time point
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Weight
|
Single time point
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Clinical parameters 4
Periodo de tiempo: Single time point
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Ethnicity
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Single time point
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Clinical parameters 5
Periodo de tiempo: Single time point
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Time from therapy initiation/Interval until study day
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Single time point
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Clinical parameters 6
Periodo de tiempo: Single time point
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Current medication*
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Single time point
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Clinical parameters 7
Periodo de tiempo: Single time point
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Secondary diagnoses
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Single time point
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Blood pressure
Periodo de tiempo: Single time point
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Blood pressure measurement
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Single time point
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Clinical examination
Periodo de tiempo: Single time point
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Standard clinical examination
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Single time point
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Questionnaire regarding psychosocial aspects
Periodo de tiempo: Single time point
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EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
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Single time point
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Blood samples 1
Periodo de tiempo: Single time point
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Presence of clonal hematopoiesis (CH)
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Single time point
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Blood samples 2
Periodo de tiempo: Single time point
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Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
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Single time point
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Blood samples 3
Periodo de tiempo: Single time point
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Clone size / variant allele frequency (VAF)
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Single time point
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Blood samples 4
Periodo de tiempo: Single time point
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Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
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Single time point
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Blood samples 5
Periodo de tiempo: Single time point
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Telomere biology parameters (e.g.
telomere length-related measures)
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Single time point
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Blood samples 6
Periodo de tiempo: Single time point
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biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
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Single time point
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MSOT 1
Periodo de tiempo: Single time point
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Oxygenated haemoglobin (HbO₂)
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Single time point
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MSOT 2
Periodo de tiempo: Single time point
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Deoxygenated haemoglobin (HHb)
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Single time point
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MSOT 3
Periodo de tiempo: Single time point
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Total haemoglobin (tHb)
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Single time point
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MSOT 4
Periodo de tiempo: Single time point
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Tissue oxygen saturation (sO₂)
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Single time point
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MSOT 5
Periodo de tiempo: Single time point
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MSOT signal intensity per region of interest
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Single time point
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MSOT 6
Periodo de tiempo: Single time point
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MSOT topogram of perfusion of the m.
gastrocnemius
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Single time point
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
14 de julio de 2026
Finalización primaria (Estimado)
31 de mayo de 2028
Finalización del estudio (Estimado)
31 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
9 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Leucemia Linfoide
- Leucemia
- Enfermedades hemic y linfáticas
- Linfoma
- Leucemia-linfoma linfoblástico de células precursoras
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Técnicas de diagnóstico, sistema respiratorio
- Pruebas de funciones respiratorias
- Recolección de muestras de sangre
- Espirometría
Otros números de identificación del estudio
- MaximALL
- DKS 2025.17 (Otro número de subvención/financiamiento: Deutsche Kinderkrebsstiftung)
- 2026-03 (Otro número de subvención/financiamiento: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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
Marco de tiempo para compartir IPD
Beginning 9 months and ending 36 months following article publication
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .