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)

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT07705178
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Jul 14, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: 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.
  • Other: 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.
  • Other: 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.

Primary Outcome Measure

Morphological lung changes (MRI) [ Time Frame: Single time point ]

Central Contacts

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