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)

Официальное название

"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)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Morphological lung changes (MRI) [Срок оценки: Single time point]
• Functional lung parameters (MRI) [Срок оценки: Single time point]
• Quantitative and functional cardiovascular changes (MRI) [Срок оценки: Single time point]

Вторичные конечные точки (12)

• DLCO [Срок оценки: Single time point]
• VA [Срок оценки: Single time point]
• KCO [Срок оценки: Single time point]
• VC [Срок оценки: single time point]
• FEV1 [Срок оценки: Single time point]
• VO2 [Срок оценки: Single time point]
• VO2max [Срок оценки: Single time point]
• RER [Срок оценки: Single time point]
• VT2 [Срок оценки: Single time point]
• VCO2 [Срок оценки: Single time point]
• HR [Срок оценки: Single time point]
• HRR [Срок оценки: Single time point]

Критерии участия

Control Group:

Критерии включения

• no cancer diagnosis
• no lung diseases
• no vascular diseases
• No subjective reduction in physical performance
• age >/= 18 years

Критерии исключения

• 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:

Критерии включения

• Completed therapy for ALL
• age >/= 3 years

Критерии исключения

• 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:

Критерии включения

• Completed therapy for lymphoma
• age >/= 3 years

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Германия · 1 центр

• Department of Pediatrics and Adolescent Medicine — Erlangen

Идентификаторы

NCT: NCT07705178 · MaximALL · DKS 2025.17 · 2026-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗