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 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
180
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Axel Karow, PD. Dr. med.
- Telefoonnummer: 09131 8533118
- E-mail: axel.karow@uk-erlangen.de
Studie Contact Back-up
- Naam: Ferdinand Knieling, Prof. Dr. med.
- Telefoonnummer: 09131 8533118
- E-mail: ferdinand.knieling@uk-erlangen.de
Studie Locaties
-
-
-
Erlangen, Duitsland, 91054
- Werving
- Department of Pediatrics and Adolescent Medicine
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: 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.
|
|
Ander: 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
|
|
Ander: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Morphological lung changes (MRI)
Tijdsspanne: Single time point
|
Morphological lung changes
|
Single time point
|
|
Functional lung parameters (MRI)
Tijdsspanne: Single time point
|
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
|
Single time point
|
|
Quantitative and functional cardiovascular changes (MRI)
Tijdsspanne: Single time point
|
Quantitative and functional cardiovascular changes of the heart
|
Single time point
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
DLCO
Tijdsspanne: Single time point
|
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
|
Single time point
|
|
VA
Tijdsspanne: Single time point
|
Alveolar Volume
|
Single time point
|
|
KCO
Tijdsspanne: Single time point
|
DLCO/VA (absolute and % of predicted value)
|
Single time point
|
|
VC
Tijdsspanne: single time point
|
VC (vital capacity) in %
|
single time point
|
|
FEV1
Tijdsspanne: Single time point
|
FEV1 (Forced Expiratory Volume in 1 Second) in %
|
Single time point
|
|
VO2
Tijdsspanne: Single time point
|
Oxygen uptake (VO2)
|
Single time point
|
|
VO2max
Tijdsspanne: Single time point
|
peak oxygen uptake (VO2max)
|
Single time point
|
|
RER
Tijdsspanne: Single time point
|
Respiratory exchange ratio (RER)
|
Single time point
|
|
VT2
Tijdsspanne: Single time point
|
Ventilatory anaerobic threshold (VT2)
|
Single time point
|
|
VCO2
Tijdsspanne: Single time point
|
Carbon dioxide output (VCO2)
|
Single time point
|
|
HR
Tijdsspanne: Single time point
|
Heart rate (HR)
|
Single time point
|
|
HRR
Tijdsspanne: Single time point
|
Heart Rate Reserve (HRR)
|
Single time point
|
|
Breath rate at VAT
Tijdsspanne: Single time point
|
Breath rate at VAT
|
Single time point
|
|
BRR
Tijdsspanne: Single time point
|
Breath rate reserve (BRR)
|
Single time point
|
|
VE
Tijdsspanne: Single time point
|
minute ventilation (VE)
|
Single time point
|
|
O2 Pulse
Tijdsspanne: Single time point
|
O2 Pulse
|
Single time point
|
|
HRV
Tijdsspanne: Single time point
|
Heart rate variability (HRV)
|
Single time point
|
|
Borg Scale
Tijdsspanne: Single time point
|
Exercise capacity (Borg Scale)
|
Single time point
|
|
Echocardiography
Tijdsspanne: Single time point
|
Myocardial function by echocardiographic strain and strain-rate imaging
|
Single time point
|
|
Clinical parameters 1
Tijdsspanne: Single time point
|
Age in years
|
Single time point
|
|
Clinical parameters 2
Tijdsspanne: Single time point
|
Gender
|
Single time point
|
|
Clinical parameters 3
Tijdsspanne: Single time point
|
Weight
|
Single time point
|
|
Clinical parameters 4
Tijdsspanne: Single time point
|
Ethnicity
|
Single time point
|
|
Clinical parameters 5
Tijdsspanne: Single time point
|
Time from therapy initiation/Interval until study day
|
Single time point
|
|
Clinical parameters 6
Tijdsspanne: Single time point
|
Current medication*
|
Single time point
|
|
Clinical parameters 7
Tijdsspanne: Single time point
|
Secondary diagnoses
|
Single time point
|
|
Blood pressure
Tijdsspanne: Single time point
|
Blood pressure measurement
|
Single time point
|
|
Clinical examination
Tijdsspanne: Single time point
|
Standard clinical examination
|
Single time point
|
|
Questionnaire regarding psychosocial aspects
Tijdsspanne: Single time point
|
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
|
Single time point
|
|
Blood samples 1
Tijdsspanne: Single time point
|
Presence of clonal hematopoiesis (CH)
|
Single time point
|
|
Blood samples 2
Tijdsspanne: Single time point
|
Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
|
Single time point
|
|
Blood samples 3
Tijdsspanne: Single time point
|
Clone size / variant allele frequency (VAF)
|
Single time point
|
|
Blood samples 4
Tijdsspanne: Single time point
|
Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
|
Single time point
|
|
Blood samples 5
Tijdsspanne: Single time point
|
Telomere biology parameters (e.g.
telomere length-related measures)
|
Single time point
|
|
Blood samples 6
Tijdsspanne: Single time point
|
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
|
Single time point
|
|
MSOT 1
Tijdsspanne: Single time point
|
Oxygenated haemoglobin (HbO₂)
|
Single time point
|
|
MSOT 2
Tijdsspanne: Single time point
|
Deoxygenated haemoglobin (HHb)
|
Single time point
|
|
MSOT 3
Tijdsspanne: Single time point
|
Total haemoglobin (tHb)
|
Single time point
|
|
MSOT 4
Tijdsspanne: Single time point
|
Tissue oxygen saturation (sO₂)
|
Single time point
|
|
MSOT 5
Tijdsspanne: Single time point
|
MSOT signal intensity per region of interest
|
Single time point
|
|
MSOT 6
Tijdsspanne: Single time point
|
MSOT topogram of perfusion of the m.
gastrocnemius
|
Single time point
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
14 juli 2026
Primaire voltooiing (Geschat)
31 mei 2028
Studie voltooiing (Geschat)
31 oktober 2028
Studieregistratiedata
Eerst ingediend
9 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juli 2026
Eerst geplaatst (Werkelijk)
15 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
9 juli 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Hematologische ziekten
- Lymfatische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Leukemie, Lymfoïde
- Leukemie
- Hemische en lymfatische ziekten
- Lymfoom
- Voorlopercel lymfoblastische leukemie-lymfoom
- Onderzoekstechnieken
- Exemplaarbehandeling
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Buren
- Chirurgische procedures, operatief
- Diagnostische technieken, ademhalingssysteem
- Ademhalingsfunctietests
- Bloedspecimenverzameling
- Spirometrie
Andere studie-ID-nummers
- MaximALL
- DKS 2025.17 (Ander subsidie-/financieringsnummer: Deutsche Kinderkrebsstiftung)
- 2026-03 (Ander subsidie-/financieringsnummer: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
Beginning 9 months and ending 36 months following article publication
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .