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NCT Number: NCT07705178

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.

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Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics and Adolescent Medicine

Erlangen, 91054, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

QOL assessment, Neuropsychological

Other

QoL assessment by EORTC SURV100, PPR

Spirometry

Diagnostic Test

During this non-invasive test, the subject must breathe against resistance through a mouthpiece.

DLCO measurement

Diagnostic Test

DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.

Echocardioraphy

Diagnostic Test

Echocardiography with strain-rate imaging.

MRI

Diagnostic Test

LF-MRI for detection of morphological and functional changes in the lung and heart.

Clinical parameters

Other

Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.

Blood samples

Diagnostic Test

Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.

MSOT

Diagnostic Test

multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD

Primary outcomes

  1. Morphological lung changes (MRI)

    Time frame: Single time point

    Morphological lung changes

  2. Functional lung parameters (MRI)

    Time frame: Single time point

    Ventilation match/mismatch, Perfusion match/mismatch, combined defects

  3. Quantitative and functional cardiovascular changes (MRI)

    Time frame: Single time point

    Quantitative and functional cardiovascular changes of the heart

Secondary outcomes

  1. DLCO

    Time frame: Single time point

    diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)

  2. VA

    Time frame: Single time point

    Alveolar Volume

  3. KCO

    Time frame: Single time point

    DLCO/VA (absolute and % of predicted value)

  4. VC

    Time frame: single time point

    VC (vital capacity) in %

  5. FEV1

    Time frame: Single time point

    FEV1 (Forced Expiratory Volume in 1 Second) in %

  6. VO2

    Time frame: Single time point

    Oxygen uptake (VO2)

  7. VO2max

    Time frame: Single time point

    peak oxygen uptake (VO2max)

  8. RER

    Time frame: Single time point

    Respiratory exchange ratio (RER)

  9. VT2

    Time frame: Single time point

    Ventilatory anaerobic threshold (VT2)

  10. VCO2

    Time frame: Single time point

    Carbon dioxide output (VCO2)

  11. HR

    Time frame: Single time point

    Heart rate (HR)

  12. HRR

    Time frame: Single time point

    Heart Rate Reserve (HRR)

  13. Breath rate at VAT

    Time frame: Single time point

    Breath rate at VAT

  14. BRR

    Time frame: Single time point

    Breath rate reserve (BRR)

  15. VE

    Time frame: Single time point

    minute ventilation (VE)

  16. O2 Pulse

    Time frame: Single time point

    O2 Pulse

  17. HRV

    Time frame: Single time point

    Heart rate variability (HRV)

  18. Borg Scale

    Time frame: Single time point

    Exercise capacity (Borg Scale)

  19. Echocardiography

    Time frame: Single time point

    Myocardial function by echocardiographic strain and strain-rate imaging

  20. Clinical parameters 1

    Time frame: Single time point

    Age in years

  21. Clinical parameters 2

    Time frame: Single time point

    Gender

  22. Clinical parameters 3

    Time frame: Single time point

    Weight

  23. Clinical parameters 4

    Time frame: Single time point

    Ethnicity

  24. Clinical parameters 5

    Time frame: Single time point

    Time from therapy initiation/Interval until study day

  25. Clinical parameters 6

    Time frame: Single time point

    Current medication*

  26. Clinical parameters 7

    Time frame: Single time point

    Secondary diagnoses

  27. Blood pressure

    Time frame: Single time point

    Blood pressure measurement

  28. Clinical examination

    Time frame: Single time point

    Standard clinical examination

  29. Questionnaire regarding psychosocial aspects

    Time frame: Single time point

    EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors

  30. Blood samples 1

    Time frame: Single time point

    Presence of clonal hematopoiesis (CH)

  31. Blood samples 2

    Time frame: Single time point

    Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)

  32. Blood samples 3

    Time frame: Single time point

    Clone size / variant allele frequency (VAF)

  33. Blood samples 4

    Time frame: Single time point

    Epigenetic aging markers (e.g. epigenetic age acceleration measures)

  34. Blood samples 5

    Time frame: Single time point

    Telomere biology parameters (e.g. telomere length-related measures)

  35. Blood samples 6

    Time frame: Single time point

    biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)

  36. MSOT 1

    Time frame: Single time point

    Oxygenated haemoglobin (HbO₂)

  37. MSOT 2

    Time frame: Single time point

    Deoxygenated haemoglobin (HHb)

  38. MSOT 3

    Time frame: Single time point

    Total haemoglobin (tHb)

  39. MSOT 4

    Time frame: Single time point

    Tissue oxygen saturation (sO₂)

  40. MSOT 5

    Time frame: Single time point

    MSOT signal intensity per region of interest

  41. MSOT 6

    Time frame: Single time point

    MSOT topogram of perfusion of the m. gastrocnemius

Study contacts

Contact information is provided by the study sponsor or research team.

Axel Karow, PD. Dr. med.

CONTACT

[email protected]

09131 8533118

Ferdinand Knieling, Prof. Dr. med.

CONTACT

[email protected]

09131 8533118

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

"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)

Acronym: MaximALL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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