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

NCT06093334 | Completed

• 1 other identifier: 23-47-B
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Morphologic lung assessment (LF-MRI)

  Morphologic changes in lung parenchyma

  Single time point (1 day)

Secondary Outcomes (23)

• 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)

Study Arms (3)

Early therapeutic effects

EXPERIMENTAL

Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Cardiopulmonary testing; Diagnostic Test: Pulmonary testing; Diagnostic Test: Blood sample

Late therapeutic effects

EXPERIMENTAL

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

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Cardiopulmonary testing; Diagnostic Test: Pulmonary testing; Diagnostic Test: Blood sample

Effects of hematopoietic stem cell transplantation

EXPERIMENTAL

Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \<18 years

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Cardiopulmonary testing; Diagnostic Test: Pulmonary testing; Diagnostic Test: Blood sample

Interventions

Low-field magnetic resonance imaging DIAGNOSTIC_TEST

Imaging of lung parenchyma and function by LF-MRI

Early therapeutic effects; Effects of hematopoietic stem cell transplantation; Late therapeutic effects

Cardiopulmonary testing DIAGNOSTIC_TEST

Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate

Early therapeutic effects; Effects of hematopoietic stem cell transplantation; Late therapeutic effects

Pulmonary testing DIAGNOSTIC_TEST

Lung function (VC%, FEV1%)

Early therapeutic effects; Effects of hematopoietic stem cell transplantation; Late therapeutic effects

Blood sample DIAGNOSTIC_TEST

Standard procedures/parameters routinely available in follow-up care after oncological treatment

Early therapeutic effects; Effects of hematopoietic stem cell transplantation; Late therapeutic effects

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
• Completed induction therapy or radiotherapy

You may not qualify if:

• 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"
• Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
• Completed intensive therapy or radiotherapy
• Pregnancy, Lactation
• Known pleural or pericardial effusion
• Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
• Marked thoracic deformities/malformations

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Pediatrics and Adolescent Medicine

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (4)

• 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.

  PMID: 32461035 BACKGROUND

• 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.

  PMID: 25696854 BACKGROUND

• 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.

  PMID: 31931503 BACKGROUND

• 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.

  PMID: 40488780 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hodgkin Disease

Interventions

Exercise Test; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Axel Karow, MD

  Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

• Ferdinand Knieling, MD

  Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

• Rafael Heiß, MD

  Institute of Radiology, University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 23, 2023
• Study Start: October 17, 2023
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows: Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication. The data will be available to researchers who provide a methodologically sound proposal. The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de. Restrictions may apply due to patient privacy and the General Data Protection Regulation.

Locations

DE (1)