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

NCT ID: NCT03553654

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2021-12-12

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CT monitoring arm

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

Group Type: EXPERIMENTAL

low dose CT

Intervention Type: DIAGNOSTIC_TEST

CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages

Interventions

low dose CT

CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Anna Narezkina

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Narezkina, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California San Diego Medical Center

San Diego, California, United States

Countries

United States

Other Identifiers

160252

Identifier Type: -

Identifier Source: org_study_id