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Trial Title:
Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD
NCT ID:
NCT06093334
Condition:
Acute Lymphoblastic Leukemia
Hodgkin Disease
Allogeneic Stem Cell Transplantation
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Hodgkin Disease
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Low-field magnetic resonance imaging
Description:
Imaging of lung parenchyma and function by LF-MRI
Arm group label:
Early therapeutic effects
Arm group label:
Effects of hematopoietic stem cell transplantation
Arm group label:
Late therapeutic effects
Intervention type:
Diagnostic Test
Intervention name:
Cardiopulmonary testing
Description:
Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary
blood gases and lactate
Arm group label:
Early therapeutic effects
Arm group label:
Effects of hematopoietic stem cell transplantation
Arm group label:
Late therapeutic effects
Intervention type:
Diagnostic Test
Intervention name:
Pulmonary testing
Description:
Lung function (VC%, FEV1%)
Arm group label:
Early therapeutic effects
Arm group label:
Effects of hematopoietic stem cell transplantation
Arm group label:
Late therapeutic effects
Intervention type:
Diagnostic Test
Intervention name:
Blood sample
Description:
Standard procedures/parameters routinely available in follow-up care after oncological
treatment
Arm group label:
Early therapeutic effects
Arm group label:
Effects of hematopoietic stem cell transplantation
Arm group label:
Late therapeutic effects
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.)
Gender:
All
Minimum age:
5 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pediatrics and Adolescent Medicine
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Axel Karow, MD
Phone:
+49 9131 8533118
Email:
axel.karow@uk-erlangen.de
Contact backup:
Last name:
Ferdinand Knieling, MD
Phone:
+49 9131 8533118
Email:
ferdinand.knieling@uk-erlangen.de
Investigator:
Last name:
Alexander Dierl, MD
Email:
Sub-Investigator
Investigator:
Last name:
Maximilian Hinsen
Email:
Sub-Investigator
Start date:
October 17, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
University of Erlangen-Nürnberg Medical School
Agency class:
Other
Source:
University of Erlangen-Nürnberg Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06093334
