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 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
180
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Axel Karow, PD. Dr. med.
- Numero di telefono: 09131 8533118
- Email: axel.karow@uk-erlangen.de
Backup dei contatti dello studio
- Nome: Ferdinand Knieling, Prof. Dr. med.
- Numero di telefono: 09131 8533118
- Email: ferdinand.knieling@uk-erlangen.de
Luoghi di studio
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Erlangen, Germania, 91054
- Reclutamento
- Department of Pediatrics and Adolescent Medicine
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Altro: 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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Altro: 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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Altro: 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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Morphological lung changes (MRI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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DLCO
Lasso di tempo: 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
Lasso di tempo: Single time point
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Alveolar Volume
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Single time point
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KCO
Lasso di tempo: 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
Lasso di tempo: single time point
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VC (vital capacity) in %
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single time point
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FEV1
Lasso di tempo: 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
Lasso di tempo: Single time point
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Oxygen uptake (VO2)
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Single time point
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VO2max
Lasso di tempo: Single time point
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peak oxygen uptake (VO2max)
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Single time point
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RER
Lasso di tempo: Single time point
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Respiratory exchange ratio (RER)
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Single time point
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VT2
Lasso di tempo: Single time point
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Ventilatory anaerobic threshold (VT2)
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Single time point
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VCO2
Lasso di tempo: Single time point
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Carbon dioxide output (VCO2)
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Single time point
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HR
Lasso di tempo: Single time point
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Heart rate (HR)
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Single time point
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HRR
Lasso di tempo: Single time point
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Heart Rate Reserve (HRR)
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Single time point
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Breath rate at VAT
Lasso di tempo: Single time point
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Breath rate at VAT
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Single time point
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BRR
Lasso di tempo: Single time point
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Breath rate reserve (BRR)
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Single time point
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VE
Lasso di tempo: Single time point
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minute ventilation (VE)
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Single time point
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O2 Pulse
Lasso di tempo: Single time point
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O2 Pulse
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Single time point
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HRV
Lasso di tempo: Single time point
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Heart rate variability (HRV)
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Single time point
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Borg Scale
Lasso di tempo: Single time point
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Exercise capacity (Borg Scale)
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Single time point
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Echocardiography
Lasso di tempo: 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
Lasso di tempo: Single time point
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Age in years
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Single time point
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Clinical parameters 2
Lasso di tempo: Single time point
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Gender
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Single time point
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Clinical parameters 3
Lasso di tempo: Single time point
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Weight
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Single time point
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Clinical parameters 4
Lasso di tempo: Single time point
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Ethnicity
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Single time point
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Clinical parameters 5
Lasso di tempo: 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
Lasso di tempo: Single time point
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Current medication*
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Single time point
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Clinical parameters 7
Lasso di tempo: Single time point
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Secondary diagnoses
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Single time point
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Blood pressure
Lasso di tempo: Single time point
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Blood pressure measurement
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Single time point
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Clinical examination
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Single time point
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Oxygenated haemoglobin (HbO₂)
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Single time point
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MSOT 2
Lasso di tempo: Single time point
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Deoxygenated haemoglobin (HHb)
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Single time point
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MSOT 3
Lasso di tempo: Single time point
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Total haemoglobin (tHb)
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Single time point
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MSOT 4
Lasso di tempo: Single time point
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Tissue oxygen saturation (sO₂)
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Single time point
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MSOT 5
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
14 luglio 2026
Completamento primario (Stimato)
31 maggio 2028
Completamento dello studio (Stimato)
31 ottobre 2028
Date di iscrizione allo studio
Primo inviato
9 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 luglio 2026
Primo Inserito (Effettivo)
15 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Leucemia, linfoide
- Leucemia
- Malattie emiche e linfatiche
- Linfoma
- Leucemia-linfoma linfoblastico a cellule precursori
- Tecniche investigative
- Gestione dei campioni
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Forature
- Procedure chirurgiche, operative
- Tecniche diagnostiche, sistema respiratorio
- Test della funzione respiratorio
- Collezione di campioni di sangue
- Spirometria
Altri numeri di identificazione dello studio
- MaximALL
- DKS 2025.17 (Altro numero di sovvenzione/finanziamento: Deutsche Kinderkrebsstiftung)
- 2026-03 (Altro numero di sovvenzione/finanziamento: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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
Periodo di condivisione IPD
Beginning 9 months and ending 36 months following article publication
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Spirometry
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Seattle Children's HospitalBoston University; University of WashingtonCompletato