Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-28 @ 8:22 PM
Study NCT ID:
NCT06093334
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2023-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-11', 'size': 379134, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-11T10:45', 'hasProtocol': True}, {'date': '2024-12-11', 'size': 121073, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-11T10:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-16', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphologic lung assessment (LF-MRI)', 'timeFrame': 'Single time point (1 day)', 'description': 'Morphologic changes in lung parenchyma'}], 'secondaryOutcomes': [{'measure': 'Functional lung assessment (LF-MRI)', 'timeFrame': 'Single time point (1 day)', 'description': 'Change in functional lung parameters'}, {'measure': 'Cardiopulmonary testing (VO2)', 'timeFrame': 'Single time point (1 day)', 'description': 'Oxygen uptake'}, {'measure': 'Cardiopulmonary testing (VO2max)', 'timeFrame': 'Single time point (1 day)', 'description': 'Peak oxygen uptake'}, {'measure': 'Cardiopulmonary testing (RER)', 'timeFrame': 'Single time point (1 day)', 'description': 'Respiratory exchange ratio'}, {'measure': 'Cardiopulmonary testing (VT2)', 'timeFrame': 'Single time point (1 day)', 'description': 'Ventilatory anaerobic threshold'}, {'measure': 'Cardiopulmonary testing (VCO2)', 'timeFrame': 'Single time point (1 day)', 'description': 'Carbon dioxide output'}, {'measure': 'Cardiopulmonary testing (HR)', 'timeFrame': 'Single time point (1 day)', 'description': 'Heart rate'}, {'measure': 'Cardiopulmonary testing (HRR)', 'timeFrame': 'Single time point (1 day)', 'description': 'Heart Rate Reserve'}, {'measure': 'Cardiopulmonary testing (Breath rate at VAT)', 'timeFrame': 'Single time point (1 day)', 'description': 'Breath rate at VAT'}, {'measure': 'Cardiopulmonary testing (BRR)', 'timeFrame': 'Single time point (1 day)', 'description': 'Breath rate reserve'}, {'measure': 'Cardiopulmonary testing (VE)', 'timeFrame': 'Single time point (1 day)', 'description': 'Minute Ventilation'}, {'measure': 'Cardiopulmonary testing (O2-Pulse)', 'timeFrame': 'Single time point (1 day)', 'description': 'O2-Pulse'}, {'measure': 'Cardiopulmonary testing (HRV)', 'timeFrame': 'Single time point (1 day)', 'description': 'Heart rate variability'}, {'measure': 'Cardiopulmonary testing (Borg-Scale)', 'timeFrame': 'Single time point (1 day)', 'description': 'Exercise capacity (Borg-Scale)'}, {'measure': 'Cardiopulmonary testing (VO2)', 'timeFrame': 'Single time point (1 day)', 'description': 'Capillary blood gases and lactate'}, {'measure': 'Cardiopulmonary testing (Strain-Analysis)', 'timeFrame': 'Single time point (1 day)', 'description': 'Strain-Analysis by echocardiography'}, {'measure': 'Pulmonary test (Lung function)', 'timeFrame': 'Single time point (1 day)', 'description': 'Lung function (VC%, FEV1%)'}, {'measure': 'Blood sample (Blood count)', 'timeFrame': 'Single time point (1 day)', 'description': 'Blood Count'}, {'measure': 'Blood sample (Enterocytes)', 'timeFrame': 'Single time point (1 day)', 'description': 'Concentration of Enterocytes'}, {'measure': 'Blood sample (Liver enzymes)', 'timeFrame': 'Single time point (1 day)', 'description': 'Liver enzymes'}, {'measure': 'Blood sample (Retention parameters)', 'timeFrame': 'Single time point (1 day)', 'description': 'Concentration of kreatinin and urea'}, {'measure': 'Weight', 'timeFrame': 'Single time point (1 day)', 'description': 'Weight of the participant in kilograms'}, {'measure': 'Height', 'timeFrame': 'Single time point (1 day)', 'description': 'Height of the participant in meters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia', 'Hodgkin Disease', 'Allogeneic Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '32461035', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25696854', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31931503', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40488780', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThis 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.\n\nThe purpose of this study is to assess early posttherapeutic changes as well as possible persistent pulmonary toxicity and change in cardiopulmonary performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Study arm: "Early therapeutic effects"\n\nInclusion Criteria:\n\n* Diagnosed acute lymphatic leukemia or Hodgkin\'s disease (HD)\n* Completed induction therapy or radiotherapy\n\nExclusion Criteria:\n\n* Pregnancy, Lactation\n* Known pleural or pericardial effusion\n* Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)\n* Marked thoracic deformities/malformations\n* Previous lung surgery\n* Injuries that do not allow physical stress diagnostics\n* Rejection of MRI imaging\n* General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, etc.)\n\nStudy arm: "Late therapeutic effects"\n\nInclusion Criteria:\n\n* Diagnosed acute lymphatic leukemia or Hodgkin\'s disease (HD)\n* Completed intensive therapy or radiotherapy\n\nExclusion Criteria:\n\n* Pregnancy, Lactation\n* Known pleural or pericardial effusion\n* Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)\n* Marked thoracic deformities/malformations\n* Previous lung surgery\n* Injuries that do not allow physical stress diagnostics\n* Rejection of MRI imaging\n* General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, etc.)\n\nStudy arm: "Effects of hematopoietic stem cell transplantation"\n\nInclusion Criteria:\n\n* Diagnosed acute lymphatic leukemia\n* Completed hematopoietic stem cell transplantation\n\nExclusion Criteria:\n\n* Pregnancy, Lactation\n* Known pleural or pericardial effusion\n* Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)\n* Marked thoracic deformities/malformations\n* Previous lung surgery\n* Injuries that do not allow physical stress diagnostics\n* Rejection of MRI imaging\n* General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, etc.)'}, 'identificationModule': {'nctId': 'NCT06093334', 'acronym': 'MinimALL', 'briefTitle': 'Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': "iMagINg of Chemotherapy-Induced Morphological and Functional Lung Changes in Childhood Acute Lymphoblastic Leukemia and Hodgkin's Disease", 'orgStudyIdInfo': {'id': '23-47-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early therapeutic effects', 'description': "Diagnosed acute lymphatic leukemia or Hodgkin's disease (HD) and completed induction therapy or radiotherapy, from 5 years to \\<18 years", 'interventionNames': ['Diagnostic Test: Low-field magnetic resonance imaging', 'Diagnostic Test: Cardiopulmonary testing', 'Diagnostic Test: Pulmonary testing', 'Diagnostic Test: Blood sample']}, {'type': 'EXPERIMENTAL', 'label': 'Late therapeutic effects', '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", 'interventionNames': ['Diagnostic Test: Low-field magnetic resonance imaging', 'Diagnostic Test: Cardiopulmonary testing', 'Diagnostic Test: Pulmonary testing', 'Diagnostic Test: Blood sample']}, {'type': 'EXPERIMENTAL', 'label': 'Effects of hematopoietic stem cell transplantation', 'description': 'Diagnosed acute lymphatic leukemia, completed hematopoietic stem cell transplantation, from 5 years to \\<18 years', 'interventionNames': ['Diagnostic Test: Low-field magnetic resonance imaging', 'Diagnostic Test: Cardiopulmonary testing', 'Diagnostic Test: Pulmonary testing', 'Diagnostic Test: Blood sample']}], 'interventions': [{'name': 'Low-field magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging of lung parenchyma and function by LF-MRI', 'armGroupLabels': ['Early therapeutic effects', 'Effects of hematopoietic stem cell transplantation', 'Late therapeutic effects']}, {'name': 'Cardiopulmonary testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Myocardial function (Strain-Analysis by echocardiography) and spiroergometry, capillary blood gases and lactate', 'armGroupLabels': ['Early therapeutic effects', 'Effects of hematopoietic stem cell transplantation', 'Late therapeutic effects']}, {'name': 'Pulmonary testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lung function (VC%, FEV1%)', 'armGroupLabels': ['Early therapeutic effects', 'Effects of hematopoietic stem cell transplantation', 'Late therapeutic effects']}, {'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard procedures/parameters routinely available in follow-up care after oncological treatment', 'armGroupLabels': ['Early therapeutic effects', 'Effects of hematopoietic stem cell transplantation', 'Late therapeutic effects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Pediatrics and Adolescent Medicine', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Axel Karow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen'}, {'name': 'Ferdinand Knieling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen'}, {'name': 'Rafael Heiß, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Radiology, University Hospital Erlangen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'accessCriteria': "The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:\n\nIndividual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication.\n\nThe data will be available to researchers who provide a methodologically sound proposal.\n\nThe data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de.\n\nRestrictions may apply due to patient privacy and the General Data Protection Regulation."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}