Back to resultsImaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD (MinimALL)
Primary Purpose
Acute Lymphoblastic Leukemia, Hodgkin Disease, Allogeneic Stem Cell Transplantation
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Low-field magnetic resonance imaging
Cardiopulmonary testing
Pulmonary testing
Blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Lymphoblastic Leukemia
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.)
Sites / Locations
- Department of Pediatrics and Adolescent MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Early therapeutic effects
Late therapeutic effects
Effects of hematopoietic stem cell transplantation
Arm Description
Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to <18 years
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
Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to <18 years
Outcomes
Primary Outcome Measures
Morphologic lung assessment (LF-MRI)
Morphologic changes in lung parenchyma
Secondary Outcome Measures
Functional lung assessment (LF-MRI)
Change in functional lung parameters
Cardiopulmonary testing (VO2)
Oxygen uptake
Cardiopulmonary testing (VO2max)
Peak oxygen uptake
Cardiopulmonary testing (RER)
Respiratory exchange ratio
Cardiopulmonary testing (VT2)
Ventilatory anaerobic threshold
Cardiopulmonary testing (VCO2)
Carbon dioxide output
Cardiopulmonary testing (HR)
Heart rate
Cardiopulmonary testing (HRR)
Heart Rate Reserve
Cardiopulmonary testing (Breath rate at VAT)
Breath rate at VAT
Cardiopulmonary testing (BRR)
Breath rate reserve
Cardiopulmonary testing (VE)
Minute Ventilation
Cardiopulmonary testing (O2-Pulse)
O2-Pulse
Cardiopulmonary testing (HRV)
Heart rate variability
Cardiopulmonary testing (Borg-Scale)
Exercise capacity (Borg-Scale)
Cardiopulmonary testing (VO2)
Capillary blood gases and lactate
Cardiopulmonary testing (Strain-Analysis)
Strain-Analysis by echocardiography
Pulmonary test (Lung function)
Lung function (VC%, FEV1%)
Blood sample (Blood count)
Blood Count
Blood sample (Enterocytes)
Concentration of Enterocytes
Blood sample (Liver enzymes)
Liver enzymes
Blood sample (Retention parameters)
Concentration of kreatinin and urea
Weight
Weight of the participant in kilograms
Height
Height of the participant in meters
Full Information
NCT ID
NCT06093334
First Posted
October 4, 2023
Last Updated
October 23, 2023
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT06093334
Brief Title
Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD
Acronym
MinimALL
Official Title
iMagINg of Chemotherapy-Induced Morphological and Functional Lung Changes in Childhood Acute Lymphoblastic Leukemia and Hodgkin's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Hodgkin Disease, Allogeneic Stem Cell Transplantation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early therapeutic effects
Arm Type
Experimental
Arm Description
Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to <18 years
Arm Title
Late therapeutic effects
Arm Type
Experimental
Arm 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
Arm Title
Effects of hematopoietic stem cell transplantation
Arm Type
Experimental
Arm Description
Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to <18 years
Intervention Type
Diagnostic Test
Intervention Name(s)
Low-field magnetic resonance imaging
Intervention Description
Imaging of lung parenchyma and function by LF-MRI
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiopulmonary testing
Intervention Description
Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate
Intervention Type
Diagnostic Test
Intervention Name(s)
Pulmonary testing
Intervention Description
Lung function (VC%, FEV1%)
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Standard procedures/parameters routinely available in follow-up care after oncological treatment
Primary Outcome Measure Information:
Title
Morphologic lung assessment (LF-MRI)
Description
Morphologic changes in lung parenchyma
Time Frame
Single time point (1 day)
Secondary Outcome Measure Information:
Title
Functional lung assessment (LF-MRI)
Description
Change in functional lung parameters
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (VO2)
Description
Oxygen uptake
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (VO2max)
Description
Peak oxygen uptake
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (RER)
Description
Respiratory exchange ratio
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (VT2)
Description
Ventilatory anaerobic threshold
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (VCO2)
Description
Carbon dioxide output
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (HR)
Description
Heart rate
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (HRR)
Description
Heart Rate Reserve
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (Breath rate at VAT)
Description
Breath rate at VAT
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (BRR)
Description
Breath rate reserve
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (VE)
Description
Minute Ventilation
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (O2-Pulse)
Description
O2-Pulse
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (HRV)
Description
Heart rate variability
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (Borg-Scale)
Description
Exercise capacity (Borg-Scale)
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (VO2)
Description
Capillary blood gases and lactate
Time Frame
Single time point (1 day)
Title
Cardiopulmonary testing (Strain-Analysis)
Description
Strain-Analysis by echocardiography
Time Frame
Single time point (1 day)
Title
Pulmonary test (Lung function)
Description
Lung function (VC%, FEV1%)
Time Frame
Single time point (1 day)
Title
Blood sample (Blood count)
Description
Blood Count
Time Frame
Single time point (1 day)
Title
Blood sample (Enterocytes)
Description
Concentration of Enterocytes
Time Frame
Single time point (1 day)
Title
Blood sample (Liver enzymes)
Description
Liver enzymes
Time Frame
Single time point (1 day)
Title
Blood sample (Retention parameters)
Description
Concentration of kreatinin and urea
Time Frame
Single time point (1 day)
Title
Weight
Description
Weight of the participant in kilograms
Time Frame
Single time point (1 day)
Title
Height
Description
Height of the participant in meters
Time Frame
Single time point (1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Karow, MD
Phone
+49913185
Ext
33118
Email
axel.karow@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dierl, MD
Phone
+49913185
Ext
33118
Email
alexander.dierl@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Karow, MD
Organizational Affiliation
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ferdinand Knieling, MD
Organizational Affiliation
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafael Heiß, MD
Organizational Affiliation
Institute of Radiology, University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics and Adolescent Medicine
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Karow, MD
Phone
+49 9131 8533118
Email
axel.karow@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Ferdinand Knieling, MD
Phone
+49 9131 8533118
Email
ferdinand.knieling@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Alexander Dierl, MD
First Name & Middle Initial & Last Name & Degree
Maximilian Hinsen
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing 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.
Citations:
PubMed Identifier
32461035
Citation
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.
Results Reference
background
PubMed Identifier
25696854
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.
Results Reference
background
PubMed Identifier
31931503
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.
Results Reference
background
Learn more about this trial
Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD
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