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

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Hodgkin Disease; Acute Lymphoblastic Leukemia; Allogeneic Stem Cell Transplantation

Treatments: Diagnostic Test: Blood sample; Diagnostic Test: Cardiopulmonary testing; Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Pulmonary testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06093334

23-47-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Early therapeutic effects

Experimental group

Description:

Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \<18 years

Treatment:

Diagnostic Test: Pulmonary testing

Diagnostic Test: Low-field magnetic resonance imaging

Diagnostic Test: Blood sample

Diagnostic Test: Cardiopulmonary testing

Late therapeutic effects

Experimental group

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

Treatment:

Diagnostic Test: Pulmonary testing

Diagnostic Test: Low-field magnetic resonance imaging

Diagnostic Test: Blood sample

Diagnostic Test: Cardiopulmonary testing

Effects of hematopoietic stem cell transplantation

Experimental group

Description:

Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \<18 years

Treatment:

Diagnostic Test: Pulmonary testing

Diagnostic Test: Low-field magnetic resonance imaging

Diagnostic Test: Blood sample

Diagnostic Test: Cardiopulmonary testing