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Spots Global Cancer Trial Database for Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD

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Trial Identification

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

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

Study ID: NCT06093334

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.

Keywords

Eligibility

Minimum Age: 5 Years

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

Department of Pediatrics and Adolescent Medicine, Erlangen, Bavaria, Germany

Contact Details

Name: Axel Karow, MD

Affiliation: Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

Role: PRINCIPAL_INVESTIGATOR

Name: Ferdinand Knieling, MD

Affiliation: Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

Role: PRINCIPAL_INVESTIGATOR

Name: Rafael Heiß, MD

Affiliation: Institute of Radiology, University Hospital Erlangen

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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