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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)

ConditionsAcute Lymphatic LeukemiaLymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

no cancer diagnosis

no lung diseases

no vascular diseases

No subjective reduction in physical performance

Disqualifiers

Pregnancy, Lactation

Known pleural or pericardial effusion

Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)

Marked thoracic deformities/malformations

Trial design

Design model

Parallel

Treatments tested in this trial

  • QOL assessment, Neuropsychological

    Other intervention

    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 intervention

    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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Control GroupOther 5 interventions
Group B: Survivors of leukemiaOther 8 interventions
Group C: Survivors of lymphomaOther 8 interventions

Trial outcomes

Primary outcomes

1

Morphological lung changes (MRI)

Morphological lung changes

Time frame
Single time point
2

Functional lung parameters (MRI)

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

Time frame
Single time point
3

Quantitative and functional cardiovascular changes (MRI)

Quantitative and functional cardiovascular changes of the heart

Time frame
Single time point

Secondary outcomes

1

DLCO

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

Time frame
Single time point
2

VA

Alveolar Volume

Time frame
Single time point
3

KCO

DLCO/VA (absolute and % of predicted value)

Time frame
Single time point
4

VC

VC (vital capacity) in %

Time frame
single time point

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Erlangen-Nürnberg Medical School

Lead sponsor

Source ClinicalTrials.gov
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