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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04461223
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment
Cardiotoxicity Osteosarcoma Myocardial Injury Chemotherapy Induced Systolic Dysfunction Doxorubicin Induced Cardiomyopathy Diagnostic Test: contrast-enhanced cardiac magnetic resonance imaging(MAGNETOM Aera 1.5T)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Evaluation of Myocardial Injury After Anthracycline Chemotherapy in Osteosarcoma Patients Using CMR
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021



Intervention Details:
  • Diagnostic Test: contrast-enhanced cardiac magnetic resonance imaging(MAGNETOM Aera 1.5T)
    CMR T1 mapping, T2mapping, T2* mapping, LGE, ECV
    Other Name: CMR


Primary Outcome Measures :
  1. Completion of chemotherapy with anthracycline drugs [ Time Frame: Through study completion, an average of 6 months. ]
    Chemotherapy regimen completed.


Secondary Outcome Measures :
  1. Incidence of Cancer therapy-related cardiac dysfunction [ Time Frame: From start of anthracycline therapy up to 6 months of anthracycline completion ]
    Cancer therapy-related cardiac dysfunction was defined as an LVEF reduction >10% from baseline, or LVEF <53%


Other Outcome Measures:
  1. Changes of T1 mapping values [ Time Frame: At timepoints 0 months, 2 months and 6 months (corresponding to the chemotherapy regimen controls) ]
    Change in T1 mapping values before and after anthracyclin chemotherapy

  2. Changes of T2 mapping values [ Time Frame: At timepoints 0 months, 2 months and 6 months (corresponding to the chemotherapy regimen controls) ]
    Change in T2 mapping values before and after anthracyclin chemotherapy

  3. Changes of T2* mapping values [ Time Frame: At timepoints 0 months, 2 months and 6 months (corresponding to the chemotherapy regimen controls) ]
    Change in T2* mapping values before and after anthracyclin chemotherapy



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Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461223


Contacts
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Contact: ELOY YIN WANG, Master +8613588721020 eloy_yw@zju.edu.cn
Contact: ZHAOMING YE, Doctor +8613606501549

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: ELOY YIN WANG, Master    +8613588721020    eloy_yw@zju.edu.cn   
Contact: ZHAOMING YE, Doctor    +8613606501549      
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Publications of Results:
Other Publications:

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04461223    
Other Study ID Numbers: 2019-523
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Osteosarcoma
CMR
T1 mapping, T2 mapping, T2* mapping, LGE, ECV
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Chemically-Induced Disorders
Osteosarcoma
Cardiomyopathies
Cardiotoxicity
Wounds and Injuries
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Radiation Injuries