Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity

Study Overview
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Brief Summary
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Prospective single arm study to evaluate a low-dose CT-based protocol for early detection of myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.

Official Title
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Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity

Conditions
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Neoplasms

Intervention / Treatment
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* Diagnostic Test: low dose CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT monitoring arm<br>18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy. | Diagnostic Test: low dose CT<br>* CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiomyopathy | Cardiomyopathy is defined as a decrease in the left ventricular ejection fraction by echocardiography of greater than 10 percentage points, to a value < 53% (normal reference value for 2D echocardiography). | 12 months after completion of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CT-based left ventricular strain parameters | Change in CT-based left ventricular strain parameters before and after the chemotherapy | 12 months after completion of chemotherapy | 
| Change in left ventricular global longitudinal strain based on echocardiography | Change in left ventricular global longitudinal strain between baseline and post-chemotherapy. | 12 months after completion of chemotherapy | 
| Change in echocardiographic left ventricular ejection fraction | left ventricular ejection fraction change between baseline and post-chemotherapy. | 12 months after completion of chemotherapy |