Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 6/14/2018 |
Start Date: | January 9, 2018 |
End Date: | June 9, 2021 |
Contact: | Anna Narezkina, MD |
Email: | anarezkina@ucsd.edu |
Phone: | 8586578530 |
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.
myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.
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.
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