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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)

9. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

180

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Deutschland
      • Erlangen, Deutschland, 91054
        • Rekrutierung
        • Department of Pediatrics and Adolescent Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Morphological lung changes (MRI)
Zeitfenster: Single time point
Morphological lung changes
Single time point
Functional lung parameters (MRI)
Zeitfenster: Single time point
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
Single time point
Quantitative and functional cardiovascular changes (MRI)
Zeitfenster: Single time point
Quantitative and functional cardiovascular changes of the heart
Single time point

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
DLCO
Zeitfenster: Single time point
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
Single time point
VA
Zeitfenster: Single time point
Alveolar Volume
Single time point
KCO
Zeitfenster: Single time point
DLCO/VA (absolute and % of predicted value)
Single time point
VC
Zeitfenster: single time point
VC (vital capacity) in %
single time point
FEV1
Zeitfenster: Single time point
FEV1 (Forced Expiratory Volume in 1 Second) in %
Single time point
VO2
Zeitfenster: Single time point
Oxygen uptake (VO2)
Single time point
VO2max
Zeitfenster: Single time point
peak oxygen uptake (VO2max)
Single time point
RER
Zeitfenster: Single time point
Respiratory exchange ratio (RER)
Single time point
VT2
Zeitfenster: Single time point
Ventilatory anaerobic threshold (VT2)
Single time point
VCO2
Zeitfenster: Single time point
Carbon dioxide output (VCO2)
Single time point
HR
Zeitfenster: Single time point
Heart rate (HR)
Single time point
HRR
Zeitfenster: Single time point
Heart Rate Reserve (HRR)
Single time point
Breath rate at VAT
Zeitfenster: Single time point
Breath rate at VAT
Single time point
BRR
Zeitfenster: Single time point
Breath rate reserve (BRR)
Single time point
VE
Zeitfenster: Single time point
minute ventilation (VE)
Single time point
O2 Pulse
Zeitfenster: Single time point
O2 Pulse
Single time point
HRV
Zeitfenster: Single time point
Heart rate variability (HRV)
Single time point
Borg Scale
Zeitfenster: Single time point
Exercise capacity (Borg Scale)
Single time point
Echocardiography
Zeitfenster: Single time point
Myocardial function by echocardiographic strain and strain-rate imaging
Single time point
Clinical parameters 1
Zeitfenster: Single time point
Age in years
Single time point
Clinical parameters 2
Zeitfenster: Single time point
Gender
Single time point
Clinical parameters 3
Zeitfenster: Single time point
Weight
Single time point
Clinical parameters 4
Zeitfenster: Single time point
Ethnicity
Single time point
Clinical parameters 5
Zeitfenster: Single time point
Time from therapy initiation/Interval until study day
Single time point
Clinical parameters 6
Zeitfenster: Single time point
Current medication*
Single time point
Clinical parameters 7
Zeitfenster: Single time point
Secondary diagnoses
Single time point
Blood pressure
Zeitfenster: Single time point
Blood pressure measurement
Single time point
Clinical examination
Zeitfenster: Single time point
Standard clinical examination
Single time point
Questionnaire regarding psychosocial aspects
Zeitfenster: Single time point
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
Single time point
Blood samples 1
Zeitfenster: Single time point
Presence of clonal hematopoiesis (CH)
Single time point
Blood samples 2
Zeitfenster: Single time point
Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)
Single time point
Blood samples 3
Zeitfenster: Single time point
Clone size / variant allele frequency (VAF)
Single time point
Blood samples 4
Zeitfenster: Single time point
Epigenetic aging markers (e.g. epigenetic age acceleration measures)
Single time point
Blood samples 5
Zeitfenster: Single time point
Telomere biology parameters (e.g. telomere length-related measures)
Single time point
Blood samples 6
Zeitfenster: Single time point
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
Single time point
MSOT 1
Zeitfenster: Single time point
Oxygenated haemoglobin (HbO₂)
Single time point
MSOT 2
Zeitfenster: Single time point
Deoxygenated haemoglobin (HHb)
Single time point
MSOT 3
Zeitfenster: Single time point
Total haemoglobin (tHb)
Single time point
MSOT 4
Zeitfenster: Single time point
Tissue oxygen saturation (sO₂)
Single time point
MSOT 5
Zeitfenster: Single time point
MSOT signal intensity per region of interest
Single time point
MSOT 6
Zeitfenster: Single time point
MSOT topogram of perfusion of the m. gastrocnemius
Single time point

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Erlangen-Nürnberg Medical School

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

14. Juli 2026

Primärer Abschluss (Geschätzt)

31. Mai 2028

Studienabschluss (Geschätzt)

31. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

9. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juli 2026

Zuerst gepostet (Tatsächlich)

15. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MaximALL
  • DKS 2025.17 (Andere Zuschuss-/Finanzierungsnummer: Deutsche Kinderkrebsstiftung)
  • 2026-03 (Andere Zuschuss-/Finanzierungsnummer: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Zeitrahmen

Beginning 9 months and ending 36 months following article publication

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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