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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. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

180

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Německo
      • Erlangen, Německo, 91054
        • Nábor
        • Department of Pediatrics and Adolescent Medicine

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: 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.
Diagnostický test: Spirometry
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
Diagnostický test: DLCO measurement
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Diagnostický test: Echocardioraphy
Echocardiography with strain-rate imaging.
Diagnostický test: MRI
LF-MRI for detection of morphological and functional changes in the lung and heart.
Jiný: Clinical parameters
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
Jiný: 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.
Diagnostický test: Spirometry
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
Diagnostický test: DLCO measurement
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Diagnostický test: Echocardioraphy
Echocardiography with strain-rate imaging.
Diagnostický test: MRI
LF-MRI for detection of morphological and functional changes in the lung and heart.
Jiný: Clinical parameters
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
Jiný: QOL assessment, Neuropsychological
QoL assessment by EORTC SURV100, PPR
Diagnostický test: Blood samples
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
Diagnostický test: MSOT
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
Jiný: 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.
Diagnostický test: Spirometry
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
Diagnostický test: DLCO measurement
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Diagnostický test: Echocardioraphy
Echocardiography with strain-rate imaging.
Diagnostický test: MRI
LF-MRI for detection of morphological and functional changes in the lung and heart.
Jiný: Clinical parameters
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
Jiný: QOL assessment, Neuropsychological
QoL assessment by EORTC SURV100, PPR
Diagnostický test: Blood samples
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
Diagnostický test: MSOT
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Morphological lung changes (MRI)
Časové okno: Single time point
Morphological lung changes
Single time point
Functional lung parameters (MRI)
Časové okno: Single time point
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
Single time point
Quantitative and functional cardiovascular changes (MRI)
Časové okno: Single time point
Quantitative and functional cardiovascular changes of the heart
Single time point

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
DLCO
Časové okno: Single time point
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
Single time point
VA
Časové okno: Single time point
Alveolar Volume
Single time point
KCO
Časové okno: Single time point
DLCO/VA (absolute and % of predicted value)
Single time point
VC
Časové okno: single time point
VC (vital capacity) in %
single time point
FEV1
Časové okno: Single time point
FEV1 (Forced Expiratory Volume in 1 Second) in %
Single time point
VO2
Časové okno: Single time point
Oxygen uptake (VO2)
Single time point
VO2max
Časové okno: Single time point
peak oxygen uptake (VO2max)
Single time point
RER
Časové okno: Single time point
Respiratory exchange ratio (RER)
Single time point
VT2
Časové okno: Single time point
Ventilatory anaerobic threshold (VT2)
Single time point
VCO2
Časové okno: Single time point
Carbon dioxide output (VCO2)
Single time point
HR
Časové okno: Single time point
Heart rate (HR)
Single time point
HRR
Časové okno: Single time point
Heart Rate Reserve (HRR)
Single time point
Breath rate at VAT
Časové okno: Single time point
Breath rate at VAT
Single time point
BRR
Časové okno: Single time point
Breath rate reserve (BRR)
Single time point
VE
Časové okno: Single time point
minute ventilation (VE)
Single time point
O2 Pulse
Časové okno: Single time point
O2 Pulse
Single time point
HRV
Časové okno: Single time point
Heart rate variability (HRV)
Single time point
Borg Scale
Časové okno: Single time point
Exercise capacity (Borg Scale)
Single time point
Echocardiography
Časové okno: Single time point
Myocardial function by echocardiographic strain and strain-rate imaging
Single time point
Clinical parameters 1
Časové okno: Single time point
Age in years
Single time point
Clinical parameters 2
Časové okno: Single time point
Gender
Single time point
Clinical parameters 3
Časové okno: Single time point
Weight
Single time point
Clinical parameters 4
Časové okno: Single time point
Ethnicity
Single time point
Clinical parameters 5
Časové okno: Single time point
Time from therapy initiation/Interval until study day
Single time point
Clinical parameters 6
Časové okno: Single time point
Current medication*
Single time point
Clinical parameters 7
Časové okno: Single time point
Secondary diagnoses
Single time point
Blood pressure
Časové okno: Single time point
Blood pressure measurement
Single time point
Clinical examination
Časové okno: Single time point
Standard clinical examination
Single time point
Questionnaire regarding psychosocial aspects
Časové okno: Single time point
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
Single time point
Blood samples 1
Časové okno: Single time point
Presence of clonal hematopoiesis (CH)
Single time point
Blood samples 2
Časové okno: Single time point
Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)
Single time point
Blood samples 3
Časové okno: Single time point
Clone size / variant allele frequency (VAF)
Single time point
Blood samples 4
Časové okno: Single time point
Epigenetic aging markers (e.g. epigenetic age acceleration measures)
Single time point
Blood samples 5
Časové okno: Single time point
Telomere biology parameters (e.g. telomere length-related measures)
Single time point
Blood samples 6
Časové okno: Single time point
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
Single time point
MSOT 1
Časové okno: Single time point
Oxygenated haemoglobin (HbO₂)
Single time point
MSOT 2
Časové okno: Single time point
Deoxygenated haemoglobin (HHb)
Single time point
MSOT 3
Časové okno: Single time point
Total haemoglobin (tHb)
Single time point
MSOT 4
Časové okno: Single time point
Tissue oxygen saturation (sO₂)
Single time point
MSOT 5
Časové okno: Single time point
MSOT signal intensity per region of interest
Single time point
MSOT 6
Časové okno: Single time point
MSOT topogram of perfusion of the m. gastrocnemius
Single time point

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Erlangen-Nürnberg Medical School

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

14. července 2026

Primární dokončení (Odhadovaný)

31. května 2028

Dokončení studie (Odhadovaný)

31. října 2028

Termíny zápisu do studia

První předloženo

9. července 2026

První předloženo, které splnilo kritéria kontroly kvality

9. července 2026

První zveřejněno (Aktuální)

15. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MaximALL
  • DKS 2025.17 (Jiné číslo grantu/financování: Deutsche Kinderkrebsstiftung)
  • 2026-03 (Jiné číslo grantu/financování: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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

Časový rámec sdílení IPD

Beginning 9 months and ending 36 months following article publication

Kritéria přístupu pro sdílení 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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