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

Acute Lymphoblastic Leukemia Clinical Trial

— MinimALL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093334
• Other study ID #: 23-47-B
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Axel Karow, MD
• Phone: +49913185
• Email: axel.karow[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Allogeneic Stem Cell Transplantation
• Hodgkin Disease
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Pediatrics and Adolescent Medicine	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphologic lung assessment (LF-MRI)	Morphologic changes in lung parenchyma	Single time point (1 day)
Secondary	Functional lung assessment (LF-MRI)	Change in functional lung parameters	Single time point (1 day)
Secondary	Cardiopulmonary testing (VO2)	Oxygen uptake	Single time point (1 day)
Secondary	Cardiopulmonary testing (VO2max)	Peak oxygen uptake	Single time point (1 day)
Secondary	Cardiopulmonary testing (RER)	Respiratory exchange ratio	Single time point (1 day)
Secondary	Cardiopulmonary testing (VT2)	Ventilatory anaerobic threshold	Single time point (1 day)
Secondary	Cardiopulmonary testing (VCO2)	Carbon dioxide output	Single time point (1 day)
Secondary	Cardiopulmonary testing (HR)	Heart rate	Single time point (1 day)
Secondary	Cardiopulmonary testing (HRR)	Heart Rate Reserve	Single time point (1 day)
Secondary	Cardiopulmonary testing (Breath rate at VAT)	Breath rate at VAT	Single time point (1 day)
Secondary	Cardiopulmonary testing (BRR)	Breath rate reserve	Single time point (1 day)
Secondary	Cardiopulmonary testing (VE)	Minute Ventilation	Single time point (1 day)
Secondary	Cardiopulmonary testing (O2-Pulse)	O2-Pulse	Single time point (1 day)
Secondary	Cardiopulmonary testing (HRV)	Heart rate variability	Single time point (1 day)
Secondary	Cardiopulmonary testing (Borg-Scale)	Exercise capacity (Borg-Scale)	Single time point (1 day)
Secondary	Cardiopulmonary testing (VO2)	Capillary blood gases and lactate	Single time point (1 day)
Secondary	Cardiopulmonary testing (Strain-Analysis)	Strain-Analysis by echocardiography	Single time point (1 day)
Secondary	Pulmonary test (Lung function)	Lung function (VC%, FEV1%)	Single time point (1 day)
Secondary	Blood sample (Blood count)	Blood Count	Single time point (1 day)
Secondary	Blood sample (Enterocytes)	Concentration of Enterocytes	Single time point (1 day)
Secondary	Blood sample (Liver enzymes)	Liver enzymes	Single time point (1 day)
Secondary	Blood sample (Retention parameters)	Concentration of kreatinin and urea	Single time point (1 day)
Secondary	Weight	Weight of the participant in kilograms	Single time point (1 day)
Secondary	Height	Height of the participant in meters	Single time point (1 day)