MinimALL
iMagINg of Chemotherapy-Induced Morphological and Functional Lung Changes in Childhood Acute Lymphoblastic Leukemia and Hodgkin's Disease
Sponsor study identifier
interventional
27
1 country
1
Study Start
October 17, 2023
Actual (reported)Primary Completion
December 9, 2024
Actual (reported)Study Completion
December 9, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 9, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 4, 2023
Actual (reported)October 17, 2023
Actual (reported)October 23, 2023
Actual (reported)December 9, 2024
Actual (reported)December 9, 2024
Actual (reported)Morphologic lung assessment (LF-MRI)
Morphologic changes in lung parenchyma
Single time point (1 day)
Functional lung assessment (LF-MRI)
Single time point (1 day)
Cardiopulmonary testing (VO2)
Single time point (1 day)
Cardiopulmonary testing (VO2max)
Single time point (1 day)
Cardiopulmonary testing (RER)
Single time point (1 day)
Cardiopulmonary testing (VT2)
Single time point (1 day)
Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years
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
Imaging of lung parenchyma and function by LF-MRI
Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate
Department of Pediatrics and Adolescent Medicine
Erlangen, Bavaria, 91054, Germany
Erdmann F, Frederiksen LE, Bonaventure A, Mader L, Hasle H, Robison LL, Winther JF. Childhood cancer: Survival, treatment modalities, late effects and improvements over time. Cancer Epidemiol. 2021 Apr;71(Pt B):101733. doi: 10.1016/j.canep.2020.101733. Epub 2020 May 24.
Silverman LB. Balancing cure and long-term risks in acute lymphoblastic leukemia. Hematology Am Soc Hematol Educ Program. 2014 Dec 5;2014(1):190-7. doi: 10.1182/asheducation-2014.1.190. Epub 2014 Nov 18.
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
27 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2023
First Posted
October 23, 2023
Study Start
October 17, 2023
Actual (reported)Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \<18 years
Lung function (VC%, FEV1%)
Standard procedures/parameters routinely available in follow-up care after oncological treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Gebauer J, Baust K, Bardi E, Grabow D, Stein A, van der Pal HJ, Calaminus G, Langer T. Guidelines for Long-Term Follow-Up after Childhood Cancer: Practical Implications for the Daily Work. Oncol Res Treat. 2020;43(3):61-69. doi: 10.1159/000504200. Epub 2020 Jan 13.
Huber F, Schoeffl I, Mueller N, Dierl A, Wild EM, Naumann-Bartsch N, Karow A, Knieling F, Woelfle J, Dittrich S, Anderheiden F. What about the heart - pediatric ALL survivors show cardiopulmonary limitations in the MinimALL Study. Eur J Pediatr. 2025 Jun 9;184(7):406. doi: 10.1007/s00431-025-06243-0.
Primary Completion
December 9, 2024
Actual (reported)Study Completion
December 9, 2024
Actual (reported)Last Updated
December 17, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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