Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
Neoplasms
About this trial
This is an interventional diagnostic trial for Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent.
- 18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at UCSD Medical Center.
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Women of child-bearing potential must have a negative pregnancy test during the screening period.
Exclusion Criteria:
- Prior chemotherapy with anthracycline;
- Persistent tachycardia (heart rate>90);
- LVEF<53% or history of cardiomyopathy or decompensated heart failure;
- Baseline GLS below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of Echocardiographic images;
- Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment;
- Moderate or severe valvular heart disease;
- Prior allergy or intolerance to iodinated contrast;
- Renal failure (GFR<30, creatinine >1.5);
- Cancer involvement of the heart.
Sites / Locations
- University of California San Diego Medical Center
Arms of the Study
Arm 1
Experimental
CT monitoring arm
18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.