NCT06093334

Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD

iMagINg of Chemotherapy-Induced Morphological and Functional Lung Changes in Childhood Acute Lymphoblastic Leukemia and Hodgkin's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia
• Hodgkin Disease
• Allogeneic Stem Cell Transplantation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Low-field magnetic resonance imaging	Imaging of lung parenchyma and function by LF-MRI
DIAGNOSTIC_TEST	Cardiopulmonary testing	Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate
DIAGNOSTIC_TEST	Pulmonary testing	Lung function (VC%, FEV1%)
DIAGNOSTIC_TEST	Blood sample	Standard procedures/parameters routinely available in follow-up care after oncological treatment

Timeline

• Start date: 2023-10-17
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2023-10-23
• Last updated: 2024-12-17

Locations

1 site across 1 country: Germany