Clinical trial NCT03553654: Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
Official title: Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: cardiomyopathy
timeFrame: 12 months after completion of chemotherapy
Secondary outcomes:
measure: Change in CT-based left ventricular strain parameters
timeFrame: 12 months after completion of chemotherapy
measure: Change in left ventricular global longitudinal strain based on echocardiography
timeFrame: 12 months after completion of chemotherapy
measure: Change in echocardiographic left ventricular ejection fraction
timeFrame: 12 months after completion of chemotherapy
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
Study officials:
affiliation: UCSD
name: Anna Narezkina, MD
role: PRINCIPAL_INVESTIGATOR
References: