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NCT Number: NCT06093334

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Low-field magnetic resonance imaging

Diagnostic Test

Imaging of lung parenchyma and function by LF-MRI

Cardiopulmonary testing

Diagnostic Test

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

Pulmonary testing

Diagnostic Test

Lung function (VC%, FEV1%)

Blood sample

Diagnostic Test

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

Primary outcomes

  1. Morphologic lung assessment (LF-MRI)

    Time frame: Single time point (1 day)

    Morphologic changes in lung parenchyma

Secondary outcomes

  1. Functional lung assessment (LF-MRI)

    Time frame: Single time point (1 day)

    Change in functional lung parameters

  2. Cardiopulmonary testing (VO2)

    Time frame: Single time point (1 day)

    Oxygen uptake

  3. Cardiopulmonary testing (VO2max)

    Time frame: Single time point (1 day)

    Peak oxygen uptake

  4. Cardiopulmonary testing (RER)

    Time frame: Single time point (1 day)

    Respiratory exchange ratio

  5. Cardiopulmonary testing (VT2)

    Time frame: Single time point (1 day)

    Ventilatory anaerobic threshold

  6. Cardiopulmonary testing (VCO2)

    Time frame: Single time point (1 day)

    Carbon dioxide output

  7. Cardiopulmonary testing (HR)

    Time frame: Single time point (1 day)

    Heart rate

  8. Cardiopulmonary testing (HRR)

    Time frame: Single time point (1 day)

    Heart Rate Reserve

  9. Cardiopulmonary testing (Breath rate at VAT)

    Time frame: Single time point (1 day)

    Breath rate at VAT

  10. Cardiopulmonary testing (BRR)

    Time frame: Single time point (1 day)

    Breath rate reserve

  11. Cardiopulmonary testing (VE)

    Time frame: Single time point (1 day)

    Minute Ventilation

  12. Cardiopulmonary testing (O2-Pulse)

    Time frame: Single time point (1 day)

    O2-Pulse

  13. Cardiopulmonary testing (HRV)

    Time frame: Single time point (1 day)

    Heart rate variability

  14. Cardiopulmonary testing (Borg-Scale)

    Time frame: Single time point (1 day)

    Exercise capacity (Borg-Scale)

  15. Cardiopulmonary testing (VO2)

    Time frame: Single time point (1 day)

    Capillary blood gases and lactate

  16. Cardiopulmonary testing (Strain-Analysis)

    Time frame: Single time point (1 day)

    Strain-Analysis by echocardiography

  17. Pulmonary test (Lung function)

    Time frame: Single time point (1 day)

    Lung function (VC%, FEV1%)

  18. Blood sample (Blood count)

    Time frame: Single time point (1 day)

    Blood Count

  19. Blood sample (Enterocytes)

    Time frame: Single time point (1 day)

    Concentration of Enterocytes

  20. Blood sample (Liver enzymes)

    Time frame: Single time point (1 day)

    Liver enzymes

  21. Blood sample (Retention parameters)

    Time frame: Single time point (1 day)

    Concentration of kreatinin and urea

  22. Weight

    Time frame: Single time point (1 day)

    Weight of the participant in kilograms

  23. Height

    Time frame: Single time point (1 day)

    Height of the participant in meters

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: MinimALL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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