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)

July 9, 2026 updated by: Ferdinand Knieling, University of Erlangen-Nürnberg Medical School

"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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Department of Pediatrics and Adolescent Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
Other: QOL assessment, Neuropsychological
QoL assessment by EORTC SURV100, PPR
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
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.
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.
Other: QOL assessment, Neuropsychological
QoL assessment by EORTC SURV100, PPR
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphological lung changes (MRI)
Time Frame: Single time point
Morphological lung changes
Single time point
Functional lung parameters (MRI)
Time Frame: Single time point
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
Single time point
Quantitative and functional cardiovascular changes (MRI)
Time Frame: Single time point
Quantitative and functional cardiovascular changes of the heart
Single time point

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DLCO
Time Frame: Single time point
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
Single time point
VA
Time Frame: Single time point
Alveolar Volume
Single time point
KCO
Time Frame: Single time point
DLCO/VA (absolute and % of predicted value)
Single time point
VC
Time Frame: single time point
VC (vital capacity) in %
single time point
FEV1
Time Frame: Single time point
FEV1 (Forced Expiratory Volume in 1 Second) in %
Single time point
VO2
Time Frame: Single time point
Oxygen uptake (VO2)
Single time point
VO2max
Time Frame: Single time point
peak oxygen uptake (VO2max)
Single time point
RER
Time Frame: Single time point
Respiratory exchange ratio (RER)
Single time point
VT2
Time Frame: Single time point
Ventilatory anaerobic threshold (VT2)
Single time point
VCO2
Time Frame: Single time point
Carbon dioxide output (VCO2)
Single time point
HR
Time Frame: Single time point
Heart rate (HR)
Single time point
HRR
Time Frame: Single time point
Heart Rate Reserve (HRR)
Single time point
Breath rate at VAT
Time Frame: Single time point
Breath rate at VAT
Single time point
BRR
Time Frame: Single time point
Breath rate reserve (BRR)
Single time point
VE
Time Frame: Single time point
minute ventilation (VE)
Single time point
O2 Pulse
Time Frame: Single time point
O2 Pulse
Single time point
HRV
Time Frame: Single time point
Heart rate variability (HRV)
Single time point
Borg Scale
Time Frame: Single time point
Exercise capacity (Borg Scale)
Single time point
Echocardiography
Time Frame: Single time point
Myocardial function by echocardiographic strain and strain-rate imaging
Single time point
Clinical parameters 1
Time Frame: Single time point
Age in years
Single time point
Clinical parameters 2
Time Frame: Single time point
Gender
Single time point
Clinical parameters 3
Time Frame: Single time point
Weight
Single time point
Clinical parameters 4
Time Frame: Single time point
Ethnicity
Single time point
Clinical parameters 5
Time Frame: Single time point
Time from therapy initiation/Interval until study day
Single time point
Clinical parameters 6
Time Frame: Single time point
Current medication*
Single time point
Clinical parameters 7
Time Frame: Single time point
Secondary diagnoses
Single time point
Blood pressure
Time Frame: Single time point
Blood pressure measurement
Single time point
Clinical examination
Time Frame: Single time point
Standard clinical examination
Single time point
Questionnaire regarding psychosocial aspects
Time Frame: Single time point
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
Single time point
Blood samples 1
Time Frame: Single time point
Presence of clonal hematopoiesis (CH)
Single time point
Blood samples 2
Time Frame: Single time point
Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)
Single time point
Blood samples 3
Time Frame: Single time point
Clone size / variant allele frequency (VAF)
Single time point
Blood samples 4
Time Frame: Single time point
Epigenetic aging markers (e.g. epigenetic age acceleration measures)
Single time point
Blood samples 5
Time Frame: Single time point
Telomere biology parameters (e.g. telomere length-related measures)
Single time point
Blood samples 6
Time Frame: Single time point
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
Single time point
MSOT 1
Time Frame: Single time point
Oxygenated haemoglobin (HbO₂)
Single time point
MSOT 2
Time Frame: Single time point
Deoxygenated haemoglobin (HHb)
Single time point
MSOT 3
Time Frame: Single time point
Total haemoglobin (tHb)
Single time point
MSOT 4
Time Frame: Single time point
Tissue oxygen saturation (sO₂)
Single time point
MSOT 5
Time Frame: Single time point
MSOT signal intensity per region of interest
Single time point
MSOT 6
Time Frame: Single time point
MSOT topogram of perfusion of the m. gastrocnemius
Single time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MaximALL
  • DKS 2025.17 (Other Grant/Funding Number: Deutsche Kinderkrebsstiftung)
  • 2026-03 (Other Grant/Funding Number: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication

IPD Sharing Access Criteria

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:

Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication.

The data will be available to researchers who provide a methodologically sound proposal.

The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de.

Restrictions may apply due to patient privacy and the General Data Protection Regulation.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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