More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL) (MaximALL)
2026년 7월 9일 업데이트: Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
"MaximALL" More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
In this study, we investigate the cardiopulmonary health of survivors who underwent cancer treatment for acute lymphoblastic leukemia (ALL) or lymphoma during childhood, compared with healthy controls.
Modern imaging techniques (MRI, MSOT, and echocardiography) as well as questionnaires assessing cardiopulmonary and mental health are used.
연구 개요
상태
모병
상세 설명
Survivors of childhood cancer have a high risk of developing late effects regarding different organ systems even years after treatment.
Our preliminary data show that a high number of our study participants who have received oncological treatment for ALL or Hodgkin's disease, develop severe ventilation and/or perfusion disorders/defects that can be detected on MRI of the lungs.
These changes are mainly observed in participants with a greater interval to the oncological treatment and we could find a significant correlation between ventilation- and perfusion defects and the timespan after diagnosis.
In spiroergometry, our patient group showed reduced aerobic capacity (ViO2 max), regardless of the time of follow-up.
Echocardiography including strain analysis resulted in suspicious findings.
The aim of our follow-up project is to validate these results in a larger patient population and to extend the investigations of long-term follow up after oncological disease/treatment in childhood and adolescence.
We are planning to conduct a multicenter study with participants (who received oncological treatment in childhood or adolescence and are now undergoing long-term-follow-up care (> 5 years after treatment,).
Therefore, we will examine morphological und functional lung changes by low field strength MRI and spiroergometry.
We plan to investigate cardiac changes by echocardiography with strain analysis and ECG.
Additionally, we would like to use multispectral optoacoustic tomography (MSOT) screening for muscle atrophy due to peripheral artery disease (PAD) as another modern imaging procedure for early detection of vascular changes.
연구 유형
중재적
등록 (추정된)
180
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Axel Karow, PD. Dr. med.
- 전화번호: 09131 8533118
- 이메일: axel.karow@uk-erlangen.de
연구 연락처 백업
- 이름: Ferdinand Knieling, Prof. Dr. med.
- 전화번호: 09131 8533118
- 이메일: ferdinand.knieling@uk-erlangen.de
연구 장소
-
-
-
Erlangen, 독일, 91054
- 모병
- Department of Pediatrics and Adolescent Medicine
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Control Group:
Inclusion Criteria:
- no cancer diagnosis
- no lung diseases
- no vascular diseases
- No subjective reduction in physical performance
- age >/= 18 years
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, copper IUD etc.)
Survivors of ALL:
Inclusion Criteria:
- Completed therapy for ALL
- age >/= 3 years
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, copper IUD etc.)
Survivors of Lymphoma:
Inclusion Criteria:
- Completed therapy for lymphoma
- age >/= 3 years
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, copper IUD etc.)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Control Group
Healthy individuals with no previous cancer diagnosis.
Volunteers will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) is performed.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
|
|
다른: Survivors of leukemia
Survivors of treatment for acute lymphatic leukemia in childhood or adolescence.
Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed.
compliant data storage).
In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
QoL assessment by EORTC SURV100, PPR
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
|
|
다른: Survivors of lymphoma
Survivors of treatment for lymphoma in childhood or adolescence.
Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed.
compliant data storage).
In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
QoL assessment by EORTC SURV100, PPR
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Morphological lung changes (MRI)
기간: Single time point
|
Morphological lung changes
|
Single time point
|
|
Functional lung parameters (MRI)
기간: Single time point
|
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
|
Single time point
|
|
Quantitative and functional cardiovascular changes (MRI)
기간: Single time point
|
Quantitative and functional cardiovascular changes of the heart
|
Single time point
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
DLCO
기간: Single time point
|
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
|
Single time point
|
|
VA
기간: Single time point
|
Alveolar Volume
|
Single time point
|
|
KCO
기간: Single time point
|
DLCO/VA (absolute and % of predicted value)
|
Single time point
|
|
VC
기간: single time point
|
VC (vital capacity) in %
|
single time point
|
|
FEV1
기간: Single time point
|
FEV1 (Forced Expiratory Volume in 1 Second) in %
|
Single time point
|
|
VO2
기간: Single time point
|
Oxygen uptake (VO2)
|
Single time point
|
|
VO2max
기간: Single time point
|
peak oxygen uptake (VO2max)
|
Single time point
|
|
RER
기간: Single time point
|
Respiratory exchange ratio (RER)
|
Single time point
|
|
VT2
기간: Single time point
|
Ventilatory anaerobic threshold (VT2)
|
Single time point
|
|
VCO2
기간: Single time point
|
Carbon dioxide output (VCO2)
|
Single time point
|
|
HR
기간: Single time point
|
Heart rate (HR)
|
Single time point
|
|
HRR
기간: Single time point
|
Heart Rate Reserve (HRR)
|
Single time point
|
|
Breath rate at VAT
기간: Single time point
|
Breath rate at VAT
|
Single time point
|
|
BRR
기간: Single time point
|
Breath rate reserve (BRR)
|
Single time point
|
|
VE
기간: Single time point
|
minute ventilation (VE)
|
Single time point
|
|
O2 Pulse
기간: Single time point
|
O2 Pulse
|
Single time point
|
|
HRV
기간: Single time point
|
Heart rate variability (HRV)
|
Single time point
|
|
Borg Scale
기간: Single time point
|
Exercise capacity (Borg Scale)
|
Single time point
|
|
Echocardiography
기간: Single time point
|
Myocardial function by echocardiographic strain and strain-rate imaging
|
Single time point
|
|
Clinical parameters 1
기간: Single time point
|
Age in years
|
Single time point
|
|
Clinical parameters 2
기간: Single time point
|
Gender
|
Single time point
|
|
Clinical parameters 3
기간: Single time point
|
Weight
|
Single time point
|
|
Clinical parameters 4
기간: Single time point
|
Ethnicity
|
Single time point
|
|
Clinical parameters 5
기간: Single time point
|
Time from therapy initiation/Interval until study day
|
Single time point
|
|
Clinical parameters 6
기간: Single time point
|
Current medication*
|
Single time point
|
|
Clinical parameters 7
기간: Single time point
|
Secondary diagnoses
|
Single time point
|
|
Blood pressure
기간: Single time point
|
Blood pressure measurement
|
Single time point
|
|
Clinical examination
기간: Single time point
|
Standard clinical examination
|
Single time point
|
|
Questionnaire regarding psychosocial aspects
기간: Single time point
|
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
|
Single time point
|
|
Blood samples 1
기간: Single time point
|
Presence of clonal hematopoiesis (CH)
|
Single time point
|
|
Blood samples 2
기간: Single time point
|
Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
|
Single time point
|
|
Blood samples 3
기간: Single time point
|
Clone size / variant allele frequency (VAF)
|
Single time point
|
|
Blood samples 4
기간: Single time point
|
Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
|
Single time point
|
|
Blood samples 5
기간: Single time point
|
Telomere biology parameters (e.g.
telomere length-related measures)
|
Single time point
|
|
Blood samples 6
기간: Single time point
|
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
|
Single time point
|
|
MSOT 1
기간: Single time point
|
Oxygenated haemoglobin (HbO₂)
|
Single time point
|
|
MSOT 2
기간: Single time point
|
Deoxygenated haemoglobin (HHb)
|
Single time point
|
|
MSOT 3
기간: Single time point
|
Total haemoglobin (tHb)
|
Single time point
|
|
MSOT 4
기간: Single time point
|
Tissue oxygen saturation (sO₂)
|
Single time point
|
|
MSOT 5
기간: Single time point
|
MSOT signal intensity per region of interest
|
Single time point
|
|
MSOT 6
기간: Single time point
|
MSOT topogram of perfusion of the m.
gastrocnemius
|
Single time point
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 14일
기본 완료 (추정된)
2028년 5월 31일
연구 완료 (추정된)
2028년 10월 31일
연구 등록 날짜
최초 제출
2026년 7월 9일
QC 기준을 충족하는 최초 제출
2026년 7월 9일
처음 게시됨 (실제)
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MaximALL
- DKS 2025.17 (기타 보조금/기금 번호: Deutsche Kinderkrebsstiftung)
- 2026-03 (기타 보조금/기금 번호: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The raw, individual and identifiable patient data are protected and are not available due to data privacy laws.
Further data sets are planned to be shared
IPD 공유 기간
Beginning 9 months and ending 36 months following article publication
IPD 공유 액세스 기준
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:
Individual 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.
The data will be available to researchers who provide a methodologically sound proposal.
The 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.
Restrictions may apply due to patient privacy and the General Data Protection Regulation.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Spirometry에 대한 임상 시험
-
Pneumacare LtdCambridge University Hospitals NHS Foundation Trust; University of Cambridge완전한
-
Seattle Children's HospitalBoston University; University of Washington완전한
-
Wake Forest University Health Sciences완전한
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Catalan Institute of Health완전한
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)완전한