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 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
180
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Axel Karow, PD. Dr. med.
- Numéro de téléphone: 09131 8533118
- E-mail: axel.karow@uk-erlangen.de
Sauvegarde des contacts de l'étude
- Nom: Ferdinand Knieling, Prof. Dr. med.
- Numéro de téléphone: 09131 8533118
- E-mail: ferdinand.knieling@uk-erlangen.de
Lieux d'étude
-
-
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Erlangen, Allemagne, 91054
- Recrutement
- Department of Pediatrics and Adolescent Medicine
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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.
|
|
Autre: 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
|
|
Autre: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Morphological lung changes (MRI)
Délai: Single time point
|
Morphological lung changes
|
Single time point
|
|
Functional lung parameters (MRI)
Délai: Single time point
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Ventilation match/mismatch, Perfusion match/mismatch, combined defects
|
Single time point
|
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Quantitative and functional cardiovascular changes (MRI)
Délai: Single time point
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Quantitative and functional cardiovascular changes of the heart
|
Single time point
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
DLCO
Délai: Single time point
|
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
|
Single time point
|
|
VA
Délai: Single time point
|
Alveolar Volume
|
Single time point
|
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KCO
Délai: Single time point
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DLCO/VA (absolute and % of predicted value)
|
Single time point
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VC
Délai: single time point
|
VC (vital capacity) in %
|
single time point
|
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FEV1
Délai: Single time point
|
FEV1 (Forced Expiratory Volume in 1 Second) in %
|
Single time point
|
|
VO2
Délai: Single time point
|
Oxygen uptake (VO2)
|
Single time point
|
|
VO2max
Délai: Single time point
|
peak oxygen uptake (VO2max)
|
Single time point
|
|
RER
Délai: Single time point
|
Respiratory exchange ratio (RER)
|
Single time point
|
|
VT2
Délai: Single time point
|
Ventilatory anaerobic threshold (VT2)
|
Single time point
|
|
VCO2
Délai: Single time point
|
Carbon dioxide output (VCO2)
|
Single time point
|
|
HR
Délai: Single time point
|
Heart rate (HR)
|
Single time point
|
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HRR
Délai: Single time point
|
Heart Rate Reserve (HRR)
|
Single time point
|
|
Breath rate at VAT
Délai: Single time point
|
Breath rate at VAT
|
Single time point
|
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BRR
Délai: Single time point
|
Breath rate reserve (BRR)
|
Single time point
|
|
VE
Délai: Single time point
|
minute ventilation (VE)
|
Single time point
|
|
O2 Pulse
Délai: Single time point
|
O2 Pulse
|
Single time point
|
|
HRV
Délai: Single time point
|
Heart rate variability (HRV)
|
Single time point
|
|
Borg Scale
Délai: Single time point
|
Exercise capacity (Borg Scale)
|
Single time point
|
|
Echocardiography
Délai: Single time point
|
Myocardial function by echocardiographic strain and strain-rate imaging
|
Single time point
|
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Clinical parameters 1
Délai: Single time point
|
Age in years
|
Single time point
|
|
Clinical parameters 2
Délai: Single time point
|
Gender
|
Single time point
|
|
Clinical parameters 3
Délai: Single time point
|
Weight
|
Single time point
|
|
Clinical parameters 4
Délai: Single time point
|
Ethnicity
|
Single time point
|
|
Clinical parameters 5
Délai: Single time point
|
Time from therapy initiation/Interval until study day
|
Single time point
|
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Clinical parameters 6
Délai: Single time point
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Current medication*
|
Single time point
|
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Clinical parameters 7
Délai: Single time point
|
Secondary diagnoses
|
Single time point
|
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Blood pressure
Délai: Single time point
|
Blood pressure measurement
|
Single time point
|
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Clinical examination
Délai: Single time point
|
Standard clinical examination
|
Single time point
|
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Questionnaire regarding psychosocial aspects
Délai: Single time point
|
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
|
Single time point
|
|
Blood samples 1
Délai: Single time point
|
Presence of clonal hematopoiesis (CH)
|
Single time point
|
|
Blood samples 2
Délai: Single time point
|
Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
|
Single time point
|
|
Blood samples 3
Délai: Single time point
|
Clone size / variant allele frequency (VAF)
|
Single time point
|
|
Blood samples 4
Délai: Single time point
|
Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
|
Single time point
|
|
Blood samples 5
Délai: Single time point
|
Telomere biology parameters (e.g.
telomere length-related measures)
|
Single time point
|
|
Blood samples 6
Délai: Single time point
|
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
|
Single time point
|
|
MSOT 1
Délai: Single time point
|
Oxygenated haemoglobin (HbO₂)
|
Single time point
|
|
MSOT 2
Délai: Single time point
|
Deoxygenated haemoglobin (HHb)
|
Single time point
|
|
MSOT 3
Délai: Single time point
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Total haemoglobin (tHb)
|
Single time point
|
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MSOT 4
Délai: Single time point
|
Tissue oxygen saturation (sO₂)
|
Single time point
|
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MSOT 5
Délai: Single time point
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MSOT signal intensity per region of interest
|
Single time point
|
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MSOT 6
Délai: Single time point
|
MSOT topogram of perfusion of the m.
gastrocnemius
|
Single time point
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
14 juillet 2026
Achèvement primaire (Estimé)
31 mai 2028
Achèvement de l'étude (Estimé)
31 octobre 2028
Dates d'inscription aux études
Première soumission
9 juillet 2026
Première soumission répondant aux critères de contrôle qualité
9 juillet 2026
Première publication (Réel)
15 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies hématologiques
- Maladies lymphatiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Leucémie, Lymphoïde
- Leucémie
- Maladies hémiques et lymphatiques
- Lymphome
- Leucémie-lymphome lymphoblastique à cellules précurseurs
- Techniques d'investigation
- Manipulation des échantillons
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Perforation
- Procédures chirurgicales, opératoires
- Techniques de diagnostic, système respiratoire
- Tests de fonction respiratoire
- Collection d'échantillons de sang
- Spirométrie
Autres numéros d'identification d'étude
- MaximALL
- DKS 2025.17 (Autre subvention/numéro de financement: Deutsche Kinderkrebsstiftung)
- 2026-03 (Autre subvention/numéro de financement: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .