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)

Official 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)

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Morphological lung changes (MRI) [Time frame: Single time point]
• Functional lung parameters (MRI) [Time frame: Single time point]
• Quantitative and functional cardiovascular changes (MRI) [Time frame: Single time point]

Secondary outcome measures (12)

• DLCO [Time frame: Single time point]
• VA [Time frame: Single time point]
• KCO [Time frame: Single time point]
• VC [Time frame: single time point]
• FEV1 [Time frame: Single time point]
• VO2 [Time frame: Single time point]
• VO2max [Time frame: Single time point]
• RER [Time frame: Single time point]
• VT2 [Time frame: Single time point]
• VCO2 [Time frame: Single time point]
• HR [Time frame: Single time point]
• HRR [Time frame: Single time point]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Germany · 1 center

• Department of Pediatrics and Adolescent Medicine — Erlangen

Identifiers

NCT: NCT07705178 · MaximALL · DKS 2025.17 · 2026-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗