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

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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.


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.
We found this trial at
1
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San Diego, California 92103
Phone: 858-657-8530
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