Department of Pediatrics and Adolescent Medicine
Erlangen, Bavaria, 91054, Germany
NCT Number: NCT06093334
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.
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Notify Me5 year–17 year
All sexes
Interventional
Not applicable
Erlangen, Bavaria, 91054, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Study arm: "Early therapeutic effects"
Inclusion criteria
Exclusion criteria
Study arm: "Late therapeutic effects"
Inclusion criteria
Exclusion criteria
Study arm: "Effects of hematopoietic stem cell transplantation"
Inclusion criteria
Exclusion criteria
Imaging of lung parenchyma and function by LF-MRI
Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate
Lung function (VC%, FEV1%)
Standard procedures/parameters routinely available in follow-up care after oncological treatment
Time frame: Single time point (1 day)
Morphologic changes in lung parenchyma
Time frame: Single time point (1 day)
Change in functional lung parameters
Time frame: Single time point (1 day)
Oxygen uptake
Time frame: Single time point (1 day)
Peak oxygen uptake
Time frame: Single time point (1 day)
Respiratory exchange ratio
Time frame: Single time point (1 day)
Ventilatory anaerobic threshold
Time frame: Single time point (1 day)
Carbon dioxide output
Time frame: Single time point (1 day)
Heart rate
Time frame: Single time point (1 day)
Heart Rate Reserve
Time frame: Single time point (1 day)
Breath rate at VAT
Time frame: Single time point (1 day)
Breath rate reserve
Time frame: Single time point (1 day)
Minute Ventilation
Time frame: Single time point (1 day)
O2-Pulse
Time frame: Single time point (1 day)
Heart rate variability
Time frame: Single time point (1 day)
Exercise capacity (Borg-Scale)
Time frame: Single time point (1 day)
Capillary blood gases and lactate
Time frame: Single time point (1 day)
Strain-Analysis by echocardiography
Time frame: Single time point (1 day)
Lung function (VC%, FEV1%)
Time frame: Single time point (1 day)
Blood Count
Time frame: Single time point (1 day)
Concentration of Enterocytes
Time frame: Single time point (1 day)
Liver enzymes
Time frame: Single time point (1 day)
Concentration of kreatinin and urea
Time frame: Single time point (1 day)
Weight of the participant in kilograms
Time frame: Single time point (1 day)
Height of the participant in meters
University of Erlangen-Nürnberg Medical School
Other
iMagINg of Chemotherapy-Induced Morphological and Functional Lung Changes in Childhood Acute Lymphoblastic Leukemia and Hodgkin's Disease
Acronym: MinimALL
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