Evaluation of Myocardial Injury After Anthracycline Chemotherapy in Osteosarcoma Patients Using CMR

NCT04461223 | Unknown DMC

• 1 other identifier: 2019-523
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cardiotoxicity; Osteosarcoma; Myocardial Injury; Chemotherapy Induced Systolic Dysfunction; Doxorubicin Induced Cardiomyopathy

Keywords

Osteosarcoma; CMR; T1 mapping, T2 mapping, T2* mapping, LGE, ECV

Outcome Measures

Primary Outcomes (1)

• Completion of chemotherapy with anthracycline drugs

  Chemotherapy regimen completed.

  Through study completion, an average of 6 months.

Secondary Outcomes (1)

• Incidence of Cancer therapy-related cardiac dysfunction

  From start of anthracycline therapy up to 6 months of anthracycline completion

Other Outcomes (3)

• Changes of T1 mapping values

  At timepoints 0 months, 2 months and 6 months (corresponding to the chemotherapy regimen controls)

• Changes of T2 mapping values

  At timepoints 0 months, 2 months and 6 months (corresponding to the chemotherapy regimen controls)

• Changes of T2* mapping values

  At timepoints 0 months, 2 months and 6 months (corresponding to the chemotherapy regimen controls)

Interventions

contrast-enhanced cardiac magnetic resonance imaging(MAGNETOM Aera 1.5T) DIAGNOSTIC_TEST

CMR T1 mapping, T2mapping, T2\* mapping, LGE, ECV

Also known as: CMR

Eligibility Criteria

• Age: 8 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All chemotherapy naive patients whose biopsy results show high grade osteosarcoma undergoing an anthracycline agent as part of their chemotherapy regimen without the underlying heart disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (11)

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• Chen 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.

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• Li 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 BACKGROUND

• Kopp 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 BACKGROUND

• Puntmann 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 BACKGROUND

• Messroghli DR, Moon JC, Ferreira VM, Grosse-Wortmann L, He T, Kellman P, Mascherbauer J, Nezafat R, Salerno M, Schelbert EB, Taylor AJ, Thompson R, Ugander M, van Heeswijk RB, Friedrich MG. Clinical recommendations for cardiovascular magnetic resonance mapping of T1, T2, T2* and extracellular volume: A consensus statement by the Society for Cardiovascular Magnetic Resonance (SCMR) endorsed by the European Association for Cardiovascular Imaging (EACVI). J Cardiovasc Magn Reson. 2017 Oct 9;19(1):75. doi: 10.1186/s12968-017-0389-8.

  PMID: 28992817 BACKGROUND

• Haaf P, Garg P, Messroghli DR, Broadbent DA, Greenwood JP, Plein S. Cardiac T1 Mapping and Extracellular Volume (ECV) in clinical practice: a comprehensive review. J Cardiovasc Magn Reson. 2016 Nov 30;18(1):89. doi: 10.1186/s12968-016-0308-4.

  PMID: 27899132 BACKGROUND

• Haslbauer JD, Lindner S, Valbuena-Lopez S, Zainal H, Zhou H, D'Angelo T, Pathan F, Arendt CA, Bug G, Serve H, Vogl TJ, Zeiher AM, Carr-White G, Nagel E, Puntmann VO. CMR imaging biosignature of cardiac involvement due to cancer-related treatment by T1 and T2 mapping. Int J Cardiol. 2019 Jan 15;275:179-186. doi: 10.1016/j.ijcard.2018.10.023. Epub 2018 Oct 11.

  PMID: 30360992 BACKGROUND

• Altaha MA, Nolan M, Marwick TH, Somerset E, Houbois C, Amir E, Yip P, Connelly KA, Michalowska M, Sussman MS, Wintersperger BJ, Thavendiranathan P. Can Quantitative CMR Tissue Characterization Adequately Identify Cardiotoxicity During Chemotherapy?: Impact of Temporal and Observer Variability. JACC Cardiovasc Imaging. 2020 Apr;13(4):951-962. doi: 10.1016/j.jcmg.2019.10.016. Epub 2019 Dec 18.

  PMID: 31864977 BACKGROUND

• Whelan JS, Bielack SS, Marina N, Smeland S, Jovic G, Hook JM, Krailo M, Anninga J, Butterfass-Bahloul T, Bohling T, Calaminus G, Capra M, Deffenbaugh C, Dhooge C, Eriksson M, Flanagan AM, Gelderblom H, Goorin A, Gorlick R, Gosheger G, Grimer RJ, Hall KS, Helmke K, Hogendoorn PC, Jundt G, Kager L, Kuehne T, Lau CC, Letson GD, Meyer J, Meyers PA, Morris C, Mottl H, Nadel H, Nagarajan R, Randall RL, Schomberg P, Schwarz R, Teot LA, Sydes MR, Bernstein M; EURAMOS collaborators. EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment. Ann Oncol. 2015 Feb;26(2):407-14. doi: 10.1093/annonc/mdu526. Epub 2014 Nov 24.

  PMID: 25421877 RESULT

• Demissei BG, Hubbard RA, Zhang L, Smith AM, Sheline K, McDonald C, Narayan V, Domchek SM, DeMichele A, Shah P, Clark AS, Fox K, Matro J, Bradbury AR, Knollman H, Getz KD, Armenian SH, Januzzi JL, Tang WHW, Liu P, Ky B. Changes in Cardiovascular Biomarkers With Breast Cancer Therapy and Associations With Cardiac Dysfunction. J Am Heart Assoc. 2020 Jan 21;9(2):e014708. doi: 10.1161/JAHA.119.014708. Epub 2020 Jan 21.

  PMID: 31959034 RESULT

MeSH Terms

Conditions

Cardiotoxicity; Osteosarcoma

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

ELOY YIN WANG, Master

CONTACT

+8613588721020; eloy_yw@zju.edu.cn

ZHAOMING YE, Doctor

CONTACT

+8613606501549

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 8, 2020
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 8, 2020

Record last verified: 2019-12

Locations

CN (1)