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)
2026年7月9日 更新者：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.
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
介入
入学 (推定)
入学
180
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Axel Karow, PD. Dr. med.
- 電話番号：09131 8533118
- メール：axel.karow@uk-erlangen.de
研究連絡先のバックアップ
- 名前：Ferdinand Knieling, Prof. Dr. med.
- 電話番号：09131 8533118
- メール：ferdinand.knieling@uk-erlangen.de
研究場所
-
-
-
Erlangen、ドイツ、91054
- 募集
- Department of Pediatrics and Adolescent Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
3
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
他の：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.
|
|
他の：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
|
|
他の：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
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Morphological lung changes (MRI)
時間枠：Single time point
|
Morphological lung changes
|
Single time point
|
|
Functional lung parameters (MRI)
時間枠：Single time point
|
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
|
Single time point
|
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Quantitative and functional cardiovascular changes (MRI)
時間枠：Single time point
|
Quantitative and functional cardiovascular changes of the heart
|
Single time point
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
DLCO
時間枠：Single time point
|
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
|
Single time point
|
|
VA
時間枠：Single time point
|
Alveolar Volume
|
Single time point
|
|
KCO
時間枠：Single time point
|
DLCO/VA (absolute and % of predicted value)
|
Single time point
|
|
VC
時間枠：single time point
|
VC (vital capacity) in %
|
single time point
|
|
FEV1
時間枠：Single time point
|
FEV1 (Forced Expiratory Volume in 1 Second) in %
|
Single time point
|
|
VO2
時間枠：Single time point
|
Oxygen uptake (VO2)
|
Single time point
|
|
VO2max
時間枠：Single time point
|
peak oxygen uptake (VO2max)
|
Single time point
|
|
RER
時間枠：Single time point
|
Respiratory exchange ratio (RER)
|
Single time point
|
|
VT2
時間枠：Single time point
|
Ventilatory anaerobic threshold (VT2)
|
Single time point
|
|
VCO2
時間枠：Single time point
|
Carbon dioxide output (VCO2)
|
Single time point
|
|
HR
時間枠：Single time point
|
Heart rate (HR)
|
Single time point
|
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HRR
時間枠：Single time point
|
Heart Rate Reserve (HRR)
|
Single time point
|
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Breath rate at VAT
時間枠：Single time point
|
Breath rate at VAT
|
Single time point
|
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BRR
時間枠：Single time point
|
Breath rate reserve (BRR)
|
Single time point
|
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VE
時間枠：Single time point
|
minute ventilation (VE)
|
Single time point
|
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O2 Pulse
時間枠：Single time point
|
O2 Pulse
|
Single time point
|
|
HRV
時間枠：Single time point
|
Heart rate variability (HRV)
|
Single time point
|
|
Borg Scale
時間枠：Single time point
|
Exercise capacity (Borg Scale)
|
Single time point
|
|
Echocardiography
時間枠：Single time point
|
Myocardial function by echocardiographic strain and strain-rate imaging
|
Single time point
|
|
Clinical parameters 1
時間枠：Single time point
|
Age in years
|
Single time point
|
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Clinical parameters 2
時間枠：Single time point
|
Gender
|
Single time point
|
|
Clinical parameters 3
時間枠：Single time point
|
Weight
|
Single time point
|
|
Clinical parameters 4
時間枠：Single time point
|
Ethnicity
|
Single time point
|
|
Clinical parameters 5
時間枠：Single time point
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Time from therapy initiation/Interval until study day
|
Single time point
|
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Clinical parameters 6
時間枠：Single time point
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Current medication*
|
Single time point
|
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Clinical parameters 7
時間枠：Single time point
|
Secondary diagnoses
|
Single time point
|
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Blood pressure
時間枠：Single time point
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Blood pressure measurement
|
Single time point
|
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Clinical examination
時間枠：Single time point
|
Standard clinical examination
|
Single time point
|
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Questionnaire regarding psychosocial aspects
時間枠：Single time point
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EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
|
Single time point
|
|
Blood samples 1
時間枠：Single time point
|
Presence of clonal hematopoiesis (CH)
|
Single time point
|
|
Blood samples 2
時間枠：Single time point
|
Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
|
Single time point
|
|
Blood samples 3
時間枠：Single time point
|
Clone size / variant allele frequency (VAF)
|
Single time point
|
|
Blood samples 4
時間枠：Single time point
|
Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
|
Single time point
|
|
Blood samples 5
時間枠：Single time point
|
Telomere biology parameters (e.g.
telomere length-related measures)
|
Single time point
|
|
Blood samples 6
時間枠：Single time point
|
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
|
Single time point
|
|
MSOT 1
時間枠：Single time point
|
Oxygenated haemoglobin (HbO₂)
|
Single time point
|
|
MSOT 2
時間枠：Single time point
|
Deoxygenated haemoglobin (HHb)
|
Single time point
|
|
MSOT 3
時間枠：Single time point
|
Total haemoglobin (tHb)
|
Single time point
|
|
MSOT 4
時間枠：Single time point
|
Tissue oxygen saturation (sO₂)
|
Single time point
|
|
MSOT 5
時間枠：Single time point
|
MSOT signal intensity per region of interest
|
Single time point
|
|
MSOT 6
時間枠：Single time point
|
MSOT topogram of perfusion of the m.
gastrocnemius
|
Single time point
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年7月14日
一次修了 (推定)
一次修了
2028年5月31日
研究の完了 (推定)
研究の完了
2028年10月31日
試験登録日
最初に提出
最初に提出
2026年7月9日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
最初の投稿
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月15日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月9日
最終確認日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- MaximALL
- DKS 2025.17 (その他の助成金/資金番号：Deutsche Kinderkrebsstiftung)
- 2026-03 (その他の助成金/資金番号：Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Beginning 9 months and ending 36 months following article publication
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。