Clinical trial · Interventional
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
NCT06093334CI-TRIAL-00083823MinimALLcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Allogeneic Stem Cell Transplantation | — | UNRESOLVED | — |
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Diagnostic Test | — | UNRESOLVED |
| Cardiopulmonary testing | Diagnostic Test | — | UNRESOLVED |
| Low-field magnetic resonance imaging | Diagnostic Test | — | UNRESOLVED |
| Pulmonary testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Early therapeutic effects
- description
- Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years
- interventionNames
- Diagnostic Test: Low-field magnetic resonance imaging
- Diagnostic Test: Cardiopulmonary testing
- Diagnostic Test: Pulmonary testing
- Diagnostic Test: Blood sample
- type
- EXPERIMENTAL
- label
- Late therapeutic effects
- description
- 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
- interventionNames
- Diagnostic Test: Low-field magnetic resonance imaging
- Diagnostic Test: Cardiopulmonary testing
- Diagnostic Test: Pulmonary testing
- Diagnostic Test: Blood sample
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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 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: "Effects of hematopoietic stem cell transplantation" Inclusion Criteria: * Diagnosed acute lymphatic leukemia * Completed hematopoietic stem cell transplantation 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.)
References
Publications (4)
- BACKGROUNDErdmann 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. PMID 32461035
- BACKGROUNDSilverman 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. PMID 25696854
- BACKGROUNDGebauer 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. PMID 31931503
- DERIVEDHuber 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. PMID 40488780