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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

Studienbeginn:
Oktober 2023

Letztes Update:
25.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphoid, Hodgkin Disease

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

Axel Karow, MD
Principal Investigator
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

Ferdinand Knieling, MD
Principal Investigator
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

Rafael Heiß, MD
Principal Investigator
Institute of Radiology, University Hospital Erlangen

Kontakt

Axel Karow, MD
Kontakt:
Phone: +49913185
Phone (ext.): 33118
E-Mail: axel.karow@uk-erlangen.de» Kontaktdaten anzeigen

Alexander Dierl, MD
Kontakt:
Phone: +49913185
Phone (ext.): 33118
E-Mail: alexander.dierl@uk-erlangen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Pediatrics and Adolescent Medicine
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Axel Karow, MD
Phone: +49 9131 8533118
E-Mail: axel.karow@uk-erlangen.de

Ferdinand Knieling, MD
Phone: +49 9131 8533118
E-Mail: ferdinand.knieling@uk-erlangen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.)

Studien-Rationale

Primary outcome:

1. Morphologic lung assessment (LF-MRI) (Time Frame - Single time point (1 day)):
Morphologic changes in lung parenchyma

Secondary outcome:

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

Studien-Arme

Experimental: Early therapeutic effects
Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to <18 years
Experimental: Late therapeutic effects
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
Experimental: Effects of hematopoietic stem cell transplantation
Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to <18 years

Geprüfte Regime

Low-field magnetic resonance imaging:
Imaging of lung parenchyma and function by LF-MRI
Cardiopulmonary testing:
Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate
Pulmonary testing:
Lung function (VC%, FEV1%)
Blood sample:
Standard procedures/parameters routinely available in follow-up care after oncological treatment

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!