Markers of Anthracycline-Related Cardiac Muscle Injury
The primary aim of this proposal is to serially evaluate imaging tests in previously
untreated patients with osteosarcoma, Ewing's Sarcoma Family of Tumors(ESFT),
rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas
whose planned treatment includes a cumulative doxorubicin dose ≥ 375 mg/m2 to determine if
serial levels of one or more of these potential markers of cardiac muscle injury obtained
prior to each infusion of doxorubicin and at the completion of chemotherapy correlate with
increasing cumulative anthracycline exposure.
The secondary aim of the study is to estimate the proportion of patients with decreased
(evaluation j - evaluation j+1) peak longitudinal systolic strain (ε) or strain rate (SR),
peak radial systolic ε or SR, peak radial systolic myocardial velocity or peak longitudinal
systolic myocardial velocity among those who have a shortening fraction (SF) ≥ 29% prior to
each infusion of anthracycline. This study will evaluate whether the serum levels of cTn-T
and/or NT-BNP will increase following doxorubicin administration. The study will evaluate
whether the serum levels of cTn-T and/or NT-BNP will increase with increasing cumulative
doxorubicin dose.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Imaging measurement of potential cardiac muscle injury markers before and after cumulative anthracycline exposure.
This study will serially evaluate imaging tests in previously untreated patients with osteosarcoma, Ewing's sarcoma family of tumors, rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes a cumulative doxorubicin dose ≥ 375 mg/m2 to determine if serial levels of one or more of these potential markers of cardiac muscle injury obtained prior to each infusion of doxorubicin and at the completion of chemotherapy correlate with increasing cumulative anthracycline exposure.
3 years
Yes
Daniel Green, MD
Principal Investigator
St. Jude Children's Research Hospital
United States: Institutional Review Board
MARCI
NCT01112800
May 2010
January 2013
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