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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Diagnostic test: low dose CT

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • University of California San Diego Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT monitoring arm; 18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.	Diagnostic test: low dose CT; CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiomyopathy	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).	12 months after completion of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CT-based left ventricular strain parameters	Change in CT-based left ventricular strain parameters before and after the chemotherapy	12 months after completion of chemotherapy
Change in left ventricular global longitudinal strain based on echocardiography	Change in left ventricular global longitudinal strain between baseline and post-chemotherapy.	12 months after completion of chemotherapy
Change in echocardiographic left ventricular ejection fraction	left ventricular ejection fraction change between baseline and post-chemotherapy.	12 months after completion of chemotherapy

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Anna Narezkina, MD, UCSD

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: 160252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No