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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" 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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07705178
Acronym
MaximALL
Enrollment
180
Registered
2026-07-15
Start date
2026-07-14
Completion date
2028-10-31
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphatic Leukemia, Lymphoma

Brief summary

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

QoL assessment by EORTC SURV100, PPR

DIAGNOSTIC_TESTSpirometry

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

DIAGNOSTIC_TESTDLCO measurement

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

DIAGNOSTIC_TESTEchocardioraphy

Echocardiography with strain-rate imaging.

DIAGNOSTIC_TESTMRI

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

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

DIAGNOSTIC_TESTBlood samples

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

DIAGNOSTIC_TESTMSOT

multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Morphological lung changes (MRI)Single time pointMorphological lung changes
Functional lung parameters (MRI)Single time pointVentilation match/mismatch, Perfusion match/mismatch, combined defects
Quantitative and functional cardiovascular changes (MRI)Single time pointQuantitative and functional cardiovascular changes of the heart

Secondary

MeasureTime frameDescription
DLCOSingle time pointdiffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
VASingle time pointAlveolar Volume
KCOSingle time pointDLCO/VA (absolute and % of predicted value)
VCsingle time pointVC (vital capacity) in %
FEV1Single time pointFEV1 (Forced Expiratory Volume in 1 Second) in %
VO2Single time pointOxygen uptake (VO2)
VO2maxSingle time pointpeak oxygen uptake (VO2max)
RERSingle time pointRespiratory exchange ratio (RER)
VT2Single time pointVentilatory anaerobic threshold (VT2)
VCO2Single time pointCarbon dioxide output (VCO2)
HRSingle time pointHeart rate (HR)
HRRSingle time pointHeart Rate Reserve (HRR)
Breath rate at VATSingle time pointBreath rate at VAT
BRRSingle time pointBreath rate reserve (BRR)
VESingle time pointminute ventilation (VE)
O2 PulseSingle time pointO2 Pulse
HRVSingle time pointHeart rate variability (HRV)
Borg ScaleSingle time pointExercise capacity (Borg Scale)
EchocardiographySingle time pointMyocardial function by echocardiographic strain and strain-rate imaging
Clinical parameters 1Single time pointAge in years
Clinical parameters 2Single time pointGender
Clinical parameters 3Single time pointWeight
Clinical parameters 4Single time pointEthnicity
Clinical parameters 5Single time pointTime from therapy initiation/Interval until study day
Clinical parameters 6Single time pointCurrent medication\*
Clinical parameters 7Single time pointSecondary diagnoses
Blood pressureSingle time pointBlood pressure measurement
Clinical examinationSingle time pointStandard clinical examination
Questionnaire regarding psychosocial aspectsSingle time pointEORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
Blood samples 1Single time pointPresence of clonal hematopoiesis (CH)
Blood samples 2Single time pointType of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)
Blood samples 3Single time pointClone size / variant allele frequency (VAF)
Blood samples 4Single time pointEpigenetic aging markers (e.g. epigenetic age acceleration measures)
Blood samples 5Single time pointTelomere biology parameters (e.g. telomere length-related measures)
Blood samples 6Single time pointbiomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
MSOT 1Single time pointOxygenated haemoglobin (HbO₂)
MSOT 2Single time pointDeoxygenated haemoglobin (HHb)
MSOT 3Single time pointTotal haemoglobin (tHb)
MSOT 4Single time pointTissue oxygen saturation (sO₂)
MSOT 5Single time pointMSOT signal intensity per region of interest
MSOT 6Single time pointMSOT topogram of perfusion of the m. gastrocnemius

Countries

Germany

Contacts

CONTACTAxel Karow, PD. Dr. med.
axel.karow@uk-erlangen.de09131 8533118
CONTACTFerdinand Knieling, Prof. Dr. med.
ferdinand.knieling@uk-erlangen.de09131 8533118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026