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. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
180
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Axel Karow, PD. Dr. med.
- Telefonnummer: 09131 8533118
- E-mail: axel.karow@uk-erlangen.de
Undersøgelse Kontakt Backup
- Navn: Ferdinand Knieling, Prof. Dr. med.
- Telefonnummer: 09131 8533118
- E-mail: ferdinand.knieling@uk-erlangen.de
Studiesteder
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Erlangen, Tyskland, 91054
- Rekruttering
- Department of Pediatrics and Adolescent Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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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Andet: 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.
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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.
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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Andet: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Morphological lung changes (MRI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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DLCO
Tidsramme: 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
Tidsramme: Single time point
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Alveolar Volume
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Single time point
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KCO
Tidsramme: 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
Tidsramme: single time point
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VC (vital capacity) in %
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single time point
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FEV1
Tidsramme: 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
Tidsramme: Single time point
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Oxygen uptake (VO2)
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Single time point
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VO2max
Tidsramme: Single time point
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peak oxygen uptake (VO2max)
|
Single time point
|
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RER
Tidsramme: Single time point
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Respiratory exchange ratio (RER)
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Single time point
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VT2
Tidsramme: Single time point
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Ventilatory anaerobic threshold (VT2)
|
Single time point
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VCO2
Tidsramme: Single time point
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Carbon dioxide output (VCO2)
|
Single time point
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HR
Tidsramme: Single time point
|
Heart rate (HR)
|
Single time point
|
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HRR
Tidsramme: Single time point
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Heart Rate Reserve (HRR)
|
Single time point
|
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Breath rate at VAT
Tidsramme: Single time point
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Breath rate at VAT
|
Single time point
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BRR
Tidsramme: Single time point
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Breath rate reserve (BRR)
|
Single time point
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VE
Tidsramme: Single time point
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minute ventilation (VE)
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Single time point
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O2 Pulse
Tidsramme: Single time point
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O2 Pulse
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Single time point
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HRV
Tidsramme: Single time point
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Heart rate variability (HRV)
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Single time point
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Borg Scale
Tidsramme: Single time point
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Exercise capacity (Borg Scale)
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Single time point
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Echocardiography
Tidsramme: 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
Tidsramme: Single time point
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Age in years
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Single time point
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Clinical parameters 2
Tidsramme: Single time point
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Gender
|
Single time point
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Clinical parameters 3
Tidsramme: Single time point
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Weight
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Single time point
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Clinical parameters 4
Tidsramme: Single time point
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Ethnicity
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Single time point
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Clinical parameters 5
Tidsramme: 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
Tidsramme: Single time point
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Current medication*
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Single time point
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Clinical parameters 7
Tidsramme: Single time point
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Secondary diagnoses
|
Single time point
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Blood pressure
Tidsramme: Single time point
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Blood pressure measurement
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Single time point
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Clinical examination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Single time point
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Oxygenated haemoglobin (HbO₂)
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Single time point
|
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MSOT 2
Tidsramme: Single time point
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Deoxygenated haemoglobin (HHb)
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Single time point
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MSOT 3
Tidsramme: Single time point
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Total haemoglobin (tHb)
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Single time point
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MSOT 4
Tidsramme: Single time point
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Tissue oxygen saturation (sO₂)
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Single time point
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MSOT 5
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
14. juli 2026
Primær færdiggørelse (Anslået)
31. maj 2028
Studieafslutning (Anslået)
31. oktober 2028
Datoer for studieregistrering
Først indsendt
9. juli 2026
Først indsendt, der opfyldte QC-kriterier
9. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukæmi, lymfoid
- Leukæmi
- Hemiske og lymfatiske sygdomme
- Lymfom
- Precursorcelle lymfoblastisk leukæmi-lymfom
- Undersøgelsesteknikker
- Håndtering af eksemplar
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Punkteringer
- Kirurgiske procedurer, operative
- Diagnostiske teknikker, åndedrætssystem
- Respiratorisk funktionstest
- Blodprøveopsamling
- Spirometri
Andre undersøgelses-id-numre
- MaximALL
- DKS 2025.17 (Andet bevillings-/finansieringsnummer: Deutsche Kinderkrebsstiftung)
- 2026-03 (Andet bevillings-/finansieringsnummer: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Beginning 9 months and ending 36 months following article publication
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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