Acute Lymphoblastic Leukemia, Hodgkin Disease, Allogeneic Stem Cell Transplantation
Conditions
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.
Interventions
DIAGNOSTIC_TESTLow-field magnetic resonance imaging
Imaging of lung parenchyma and function by LF-MRI
DIAGNOSTIC_TESTCardiopulmonary testing
Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate
DIAGNOSTIC_TESTPulmonary testing
Lung function (VC%, FEV1%)
DIAGNOSTIC_TESTBlood sample
Standard procedures/parameters routinely available in follow-up care after oncological treatment
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Study arm: Early therapeutic effects Inclusion Criteria: * Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) * Completed induction 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: Late therapeutic effects Inclusion Criteria: * Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) * Completed intensive therapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphologic lung assessment (LF-MRI) | Single time point (1 day) | Morphologic changes in lung parenchyma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary testing (VO2) | Single time point (1 day) | Oxygen uptake |
| Cardiopulmonary testing (VO2max) | Single time point (1 day) | Peak oxygen uptake |
| Cardiopulmonary testing (RER) | Single time point (1 day) | Respiratory exchange ratio |
| Cardiopulmonary testing (VT2) | Single time point (1 day) | Ventilatory anaerobic threshold |
| Cardiopulmonary testing (VCO2) | Single time point (1 day) | Carbon dioxide output |
| Cardiopulmonary testing (HR) | Single time point (1 day) | Heart rate |
| Cardiopulmonary testing (HRR) | Single time point (1 day) | Heart Rate Reserve |
| Cardiopulmonary testing (Breath rate at VAT) | Single time point (1 day) | Breath rate at VAT |
| Cardiopulmonary testing (BRR) | Single time point (1 day) | Breath rate reserve |
| Cardiopulmonary testing (VE) | Single time point (1 day) | Minute Ventilation |
| Functional lung assessment (LF-MRI) | Single time point (1 day) | Change in functional lung parameters |
| Cardiopulmonary testing (HRV) | Single time point (1 day) | Heart rate variability |
| 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 |
| Pulmonary test (Lung function) | Single time point (1 day) | Lung function (VC%, FEV1%) |
| Blood sample (Blood count) | Single time point (1 day) | Blood Count |
| Blood sample (Enterocytes) | Single time point (1 day) | Concentration of Enterocytes |
| Blood sample (Liver enzymes) | Single time point (1 day) | Liver enzymes |
| Blood sample (Retention parameters) | Single time point (1 day) | Concentration of kreatinin and urea |
| Weight | Single time point (1 day) | Weight of the participant in kilograms |
| Height | Single time point (1 day) | Height of the participant in meters |
| Cardiopulmonary testing (O2-Pulse) | Single time point (1 day) | O2-Pulse |
Countries
Germany
Outcome results
None listed