AzTrials
AzTrials

Acute Lymphoblastic LeukemiaMinimALLNCT06093334

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

A study testing Low-field magnetic resonance imaging, Cardiopulmonary testing and Pulmonary testing in people with Acute Lymphoblastic Leukemia and Hodgkin Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
Low-field magnetic resonance imaging, Cardiopulmonary testing and Pulmonary testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteGermany
Study dates
17 Oct 2023to 9 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
  • Completed induction therapy or radiotherapy
  • Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD)
  • Completed intensive therapy or radiotherapy
  • Diagnosed acute lymphatic leukemia
  • Completed hematopoietic stem cell transplantation

Who cannot join

  • 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
Show all 26Show fewer
  • 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"
  • 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"
  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Pediatrics and Adolescent Medicine

    Erlangen, Bavaria, 91054

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Low-field magnetic resonance imaging, Cardiopulmonary testing, Pulmonary testing, Blood sample
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-field magnetic resonance imagingDiagnostic test

    Imaging of lung parenchyma and function by LF-MRI

  • Cardiopulmonary testingDiagnostic test

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

  • Pulmonary testingDiagnostic test

    Lung function (VC%, FEV1%)

  • Blood sampleDiagnostic test

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

Study groups in NCT06093334
Study groupRoleWhat they receive
Early therapeutic effectsExperimentalDiagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to <18 years
Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Cardiopulmonary testing; Diagnostic Test: Pulmonary testing; Diagnostic Test: Blood sample
Late therapeutic effectsExperimentalDiagnosed 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
Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Cardiopulmonary testing; Diagnostic Test: Pulmonary testing; Diagnostic Test: Blood sample
Effects of hematopoietic stem cell transplantationExperimentalDiagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to <18 years
Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Cardiopulmonary testing; Diagnostic Test: Pulmonary testing; Diagnostic Test: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphologic lung assessment (LF-MRI)

    Morphologic changes in lung parenchyma

    Measured: Single time point (1 day)

Secondary outcomes (23)

  1. Functional lung assessment (LF-MRI)

    Change in functional lung parameters

    Measured: Single time point (1 day)

  2. Cardiopulmonary testing (VO2)

    Oxygen uptake

    Measured: Single time point (1 day)

  3. Cardiopulmonary testing (VO2max)

    Peak oxygen uptake

    Measured: Single time point (1 day)

  4. Cardiopulmonary testing (RER)

    Respiratory exchange ratio

    Measured: Single time point (1 day)

  5. Cardiopulmonary testing (VT2)

    Ventilatory anaerobic threshold

    Measured: Single time point (1 day)

  6. Cardiopulmonary testing (VCO2)

    Carbon dioxide output

    Measured: Single time point (1 day)

  7. Cardiopulmonary testing (HR)

    Heart rate

    Measured: Single time point (1 day)

  8. Cardiopulmonary testing (HRR)

    Heart Rate Reserve

    Measured: Single time point (1 day)

  9. Cardiopulmonary testing (Breath rate at VAT)

    Breath rate at VAT

    Measured: Single time point (1 day)

  10. Cardiopulmonary testing (BRR)

    Breath rate reserve

    Measured: Single time point (1 day)

  11. Cardiopulmonary testing (VE)

    Minute Ventilation

    Measured: Single time point (1 day)

  12. Cardiopulmonary testing (O2-Pulse)

    O2-Pulse

    Measured: Single time point (1 day)

  13. Cardiopulmonary testing (HRV)

    Heart rate variability

    Measured: Single time point (1 day)

  14. Cardiopulmonary testing (Borg-Scale)

    Exercise capacity (Borg-Scale)

    Measured: Single time point (1 day)

  15. Cardiopulmonary testing (VO2)

    Capillary blood gases and lactate

    Measured: Single time point (1 day)

  16. Cardiopulmonary testing (Strain-Analysis)

    Strain-Analysis by echocardiography

    Measured: Single time point (1 day)

  17. Pulmonary test (Lung function)

    Lung function (VC%, FEV1%)

    Measured: Single time point (1 day)

  18. Blood sample (Blood count)

    Blood Count

    Measured: Single time point (1 day)

  19. Blood sample (Enterocytes)

    Concentration of Enterocytes

    Measured: Single time point (1 day)

  20. Blood sample (Liver enzymes)

    Liver enzymes

    Measured: Single time point (1 day)

  21. Blood sample (Retention parameters)

    Concentration of kreatinin and urea

    Measured: Single time point (1 day)

  22. Weight

    Weight of the participant in kilograms

    Measured: Single time point (1 day)

  23. Height

    Height of the participant in meters

    Measured: Single time point (1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start17 Oct 2023
  3. Primary completion9 Dec 2024
  4. Study completion9 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093334
Sponsor's protocol ID
23-47-B
Acronym
MinimALL
Status last verified
Dec 2024
First submitted
4 Oct 2023
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 32461035

  • 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.

    PubMed 25696854

  • 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.

    PubMed 31931503

  • Huber F, Schoeffl I, Mueller N, Dierl A, Wild EM, Naumann-Bartsch N, Karow A, Knieling F, Woelfle J, Dittrich S, Anderheiden F. What about the heart - pediatric ALL survivors show cardiopulmonary limitations in the MinimALL Study. Eur J Pediatr. 2025 Jun 9;184(7):406. doi: 10.1007/s00431-025-06243-0.

    PubMed 40488780

Questions about this trial

What is this clinical trial studying?

A study testing Low-field magnetic resonance imaging, Cardiopulmonary testing and Pulmonary testing in people with Acute Lymphoblastic Leukemia and Hodgkin Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphologic lung assessment (LF-MRI) (time frame: Single time point (1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06093334, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in