Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD
NCT06093334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2024-12-17
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.
Conditions
- Acute Lymphoblastic Leukemia
- Hodgkin Disease
- Allogeneic Stem Cell Transplantation
Interventions
- 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
Sponsors & Collaborators
-
University of Erlangen-Nürnberg Medical School
lead OTHER
Principal Investigators
-
Axel Karow, MD · Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
-
Ferdinand Knieling, MD · Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
-
Rafael Heiß, MD · Institute of Radiology, University Hospital Erlangen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-17
- Primary Completion
- 2024-12-09
- Completion
- 2024-12-09
Countries
- Germany
Study Locations
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