Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD
- Conditions
- Hodgkin DiseaseAllogeneic Stem Cell TransplantationAcute Lymphoblastic Leukemia
- Interventions
- Diagnostic Test: Low-field magnetic resonance imagingDiagnostic Test: Cardiopulmonary testingDiagnostic Test: Pulmonary testingDiagnostic Test: Blood sample
- Registration Number
- NCT06093334
- Lead Sponsor
- University of Erlangen-NĂĽrnberg Medical School
- Brief Summary
With increasing cure rates of childhood cancer there is growing recognition of late effects of treatments. However, there is a lack of non-invasive and child-friendly procedures that can indicate possible late damage. This study uses morphologic and free-breathing phase-resolved functional low-field (PREFUL) magnetic resonance imaging (MRI) to identify persistent pulmonary toxicity after treatment for childhood acute lymphoblastic leukemia (ALL), Hodgkin's disease (HD) and allogeneic stem cell transplantation. Furthermore, cardiopulmonary testing is performed by means of a pulmonary function test, echocardiography with strain analysis and spiroergometry.
- Detailed Description
With increasing cure rates of childhood cancer there is growing recognition of late effects of treatments. However, there is a lack of non-invasive and child-friendly procedures that can indicate possible late damage.
This study uses morphologic and free-breathing phase-resolved functional low-field (PREFUL) magnetic resonance imaging (MRI) to identify persistent pulmonary toxicity after treatment for childhood acute lymphoblastic leukemia (ALL), Hodgkin's disease (HD) and allogeneic stem cell transplantation. The examination in the new 0.55 T MRI system does not differ in procedure and especially with regard to contraindications for an MRI examination from an examination in routinely used 1.5 or 3T devices. There is no intravenous administration of contrast medium. This method has already yielded relevant results in a previous study on the frequency of lung parenchymal changes in pediatric and adolescent patients with past SARS-CoV-2 infection detected by PCR. In addition, study participants will undergo cardiopilmonary testing by spirometry, spiroergometry and echocardiography with strain analysis to assess cardiac and pulmonary performance. For the individual patient, the duration of study participation is 120 minutes. This includes approximately 30 minutes for education and consent of study participants/parents/guardians, 30 minutes for lung function test and MRI, and 30 minutes for cardiopulmonary testing.
The purpose of this study is to assess early posttherapeutic changes as well as possible persistent pulmonary toxicity and change in cardiopulmonary performance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
- Completed induction therapy or radiotherapy
- 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, etc.)
Study arm: "Late therapeutic effects"
Inclusion Criteria:
- Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
- Completed intensive therapy or radiotherapy
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, etc.)
Study arm: "Effects of hematopoietic stem cell transplantation"
Inclusion Criteria:
- Diagnosed acute lymphatic leukemia
- Completed hematopoietic stem cell transplantation
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, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Late therapeutic effects Pulmonary testing Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed intensive therapy or radiotherapy, Patient in follow-up care, from 5 years to \<18 years Late therapeutic effects Blood sample Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed intensive therapy or radiotherapy, Patient in follow-up care, from 5 years to \<18 years Late therapeutic effects Cardiopulmonary testing Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed intensive therapy or radiotherapy, Patient in follow-up care, from 5 years to \<18 years Early therapeutic effects Low-field magnetic resonance imaging Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years Early therapeutic effects Pulmonary testing Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years Late therapeutic effects Low-field magnetic resonance imaging Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed intensive therapy or radiotherapy, Patient in follow-up care, from 5 years to \<18 years Effects of hematopoietic stem cell transplantation Cardiopulmonary testing Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \<18 years Early therapeutic effects Blood sample Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years Effects of hematopoietic stem cell transplantation Low-field magnetic resonance imaging Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \<18 years Effects of hematopoietic stem cell transplantation Pulmonary testing Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \<18 years Early therapeutic effects Cardiopulmonary testing Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years Effects of hematopoietic stem cell transplantation Blood sample Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \<18 years
- Primary Outcome Measures
Name Time Method Morphologic lung assessment (LF-MRI) Single time point (1 day) Morphologic changes in lung parenchyma
- Secondary Outcome Measures
Name Time Method Cardiopulmonary testing (RER) Single time point (1 day) Respiratory exchange ratio
Cardiopulmonary testing (VT2) Single time point (1 day) Ventilatory anaerobic threshold
Functional lung assessment (LF-MRI) Single time point (1 day) Change in functional lung parameters
Cardiopulmonary testing (HRR) Single time point (1 day) Heart Rate Reserve
Cardiopulmonary testing (Borg-Scale) Single time point (1 day) Exercise capacity (Borg-Scale)
Cardiopulmonary testing (Strain-Analysis) Single time point (1 day) Strain-Analysis by echocardiography
Blood sample (Retention parameters) Single time point (1 day) Concentration of kreatinin and urea
Cardiopulmonary testing (VO2) Single time point (1 day) Capillary blood gases and lactate
Cardiopulmonary testing (VO2max) Single time point (1 day) Peak oxygen uptake
Cardiopulmonary testing (VCO2) Single time point (1 day) Carbon dioxide output
Cardiopulmonary testing (HR) Single time point (1 day) Heart rate
Cardiopulmonary testing (BRR) Single time point (1 day) Breath rate reserve
Blood sample (Blood count) Single time point (1 day) Blood Count
Blood sample (Enterocytes) Single time point (1 day) Concentration of Enterocytes
Height Single time point (1 day) Height of the participant in meters
Cardiopulmonary testing (Breath rate at VAT) Single time point (1 day) Breath rate at VAT
Cardiopulmonary testing (HRV) Single time point (1 day) Heart rate variability
Pulmonary test (Lung function) Single time point (1 day) Lung function (VC%, FEV1%)
Blood sample (Liver enzymes) Single time point (1 day) Liver enzymes
Weight Single time point (1 day) Weight of the participant in kilograms
Cardiopulmonary testing (VE) Single time point (1 day) Minute Ventilation
Cardiopulmonary testing (O2-Pulse) Single time point (1 day) O2-Pulse
Trial Locations
- Locations (1)
Department of Pediatrics and Adolescent Medicine
🇩🇪Erlangen, Bavaria, Germany