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

University of California San Diego

Status: Completed

Conditions: Neoplasms

Treatments: Diagnostic Test: low dose CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03553654

160252

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

CT monitoring arm

Experimental group

Description:

18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.

Treatment:

Diagnostic Test: low dose CT