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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06093334
Other study ID # 23-47-B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.)

Study Design


Related Conditions & MeSH terms


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)
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