Clinical trial · Observational
Evaluation of Myocardial Injury After Anthracycline Chemotherapy in Osteosarcoma Patients Using CMR
NCT04461223CI-TRIAL-00045846unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
using a contrast-enhanced (CE) cardiac magnetic resonance imaging(CMR) which included the measurement of T1 mapping, T2 mapping, T2\* mapping and late gadolinium enhancement(LGE) sequences, as well as LVEF and extracellular volume(ECV) to evaluate the respective changes before and after anthracycline chemotherapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
| Chemotherapy Induced Systolic Dysfunction | — | UNRESOLVED | — |
| Doxorubicin Induced Cardiomyopathy | — | UNRESOLVED | — |
| Myocardial Injury | — | UNRESOLVED | — |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| contrast-enhanced cardiac magnetic resonance imaging(MAGNETOM Aera 1.5T) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Completion of chemotherapy with anthracycline drugs
- timeFrame
- Through study completion, an average of 6 months.
- description
- Chemotherapy regimen completed.
Secondary outcomes (1)
- measure
- Incidence of Cancer therapy-related cardiac dysfunction
- timeFrame
- From start of anthracycline therapy up to 6 months of anthracycline completion
- description
- Cancer therapy-related cardiac dysfunction was defined as an LVEF reduction \>10% from baseline, or LVEF \<53%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * All chemotherapy naive patients whose biopsy results show high grade osteosarcoma undergoing an anthracycline agent as part of their chemotherapy regimen * Informed consent has been signed Exclusion Criteria: * Strict contraindications to contrast-enhanced cardiac magnetic resonance imaging * Underlying heart disease:myocardial infarction, heart failure, valvular disease or cardiomyopathy * Acute or chronic kidney failure
References
Publications (11)
- BACKGROUNDLang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003. PMID 25559473
- BACKGROUNDChen Y, Huang T, Shi W, Fang J, Deng H, Cui G. Potential targets for intervention against doxorubicin-induced cardiotoxicity based on genetic studies: a systematic review of the literature. J Mol Cell Cardiol. 2020 Jan;138:88-98. doi: 10.1016/j.yjmcc.2019.11.150. Epub 2019 Nov 18. PMID 31751567
- BACKGROUNDLi J, Chang HM, Banchs J, Araujo DM, Hassan SA, Wagar EA, Yeh ETH, Meng QH. Detection of subclinical cardiotoxicity in sarcoma patients receiving continuous doxorubicin infusion or pre-treatment with dexrazoxane before bolus doxorubicin. Cardiooncology. 2020 Jan 2;6:1. doi: 10.1186/s40959-019-0056-3. eCollection 2020. PMID 32154027
- BACKGROUNDKopp LM, Womer RB, Schwartz CL, Ebb DH, Franco VI, Hall D, Barkauskas DA, Krailo MD, Grier HE, Meyers PA, Wexler LH, Marina NM, Janeway KA, Gorlick R, Bernstein ML, Lipshultz SE; Children's Oncology Group. Effects of dexrazoxane on doxorubicin-related cardiotoxicity and second malignant neoplasms in children with osteosarcoma: a report from the Children's Oncology Group. Cardiooncology. 2019 Oct 28;5:15. doi: 10.1186/s40959-019-0050-9. eCollection 2019. PMID 32154021
- BACKGROUNDPuntmann VO, Valbuena S, Hinojar R, Petersen SE, Greenwood JP, Kramer CM, Kwong RY, McCann GP, Berry C, Nagel E; SCMR Clinical Trial Writing Group. Society for Cardiovascular Magnetic Resonance (SCMR) expert consensus for CMR imaging endpoints in clinical research: part I - analytical validation and clinical qualification. J Cardiovasc Magn Reson. 2018 Sep 20;20(1):67. doi: 10.1186/s12968-018-0484-5. PMID 30231886