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

Not Applicable

Completed

• Conditions: Neoplasms
• Interventions: Diagnostic Test: low dose CT

• Registration Number: NCT03553654
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT monitoring arm	low dose CT	18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in echocardiographic left ventricular ejection fraction	12 months after completion of chemotherapy	left ventricular ejection fraction change between baseline and post-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 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

Trial Locations

Locations (1)

University of California San Diego Medical Center; 🇺🇸 San Diego, California, United States