Neoplasms
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTlow dose CT
CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and the willingness to sign a written informed consent. 2. 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. 3. 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) 4. Women of child-bearing potential must have a negative pregnancy test during the screening period.
Exclusion criteria
1. Prior chemotherapy with anthracycline; 2. Persistent tachycardia (heart rate\>90); 3. LVEF\<53% or history of cardiomyopathy or decompensated heart failure; 4. 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; 5. Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment; 6. Moderate or severe valvular heart disease; 7. Prior allergy or intolerance to iodinated contrast; 8. Renal failure (GFR\<30, creatinine \>1.5); 9. Cancer involvement of the heart.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiomyopathy | 12 months after completion of chemotherapy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CT-based left ventricular strain parameters | 12 months after completion of chemotherapy | Change in CT-based left ventricular strain parameters before and after the chemotherapy |
| Change in left ventricular global longitudinal strain based on echocardiography | 12 months after completion of chemotherapy | Change in left ventricular global longitudinal strain between baseline and post-chemotherapy. |
| Change in echocardiographic left ventricular ejection fraction | 12 months after completion of chemotherapy | left ventricular ejection fraction change between baseline and post-chemotherapy. |
Countries
United States
Outcome results
None listed