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

NCT03553654 | Completed

• 1 other identifier: 160252
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in CT-based left ventricular strain parameters

  12 months after completion of chemotherapy

• Change in left ventricular global longitudinal strain based on echocardiography

  12 months after completion of chemotherapy

• Change in echocardiographic left ventricular ejection fraction

  12 months after completion of chemotherapy

Study Arms (1)

CT monitoring arm

EXPERIMENTAL

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

Diagnostic Test: low dose CT

Interventions

low dose CT DIAGNOSTIC_TEST

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

CT monitoring arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent.
• 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.
• 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)
• Women of child-bearing potential must have a negative pregnancy test during the screening period.

You may not qualify if:

• Prior chemotherapy with anthracycline;
• Persistent tachycardia (heart rate\>90);
• LVEF\<53% or history of cardiomyopathy or decompensated heart failure;
• 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;
• Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment;
• Moderate or severe valvular heart disease;
• Prior allergy or intolerance to iodinated contrast;
• Renal failure (GFR\<30, creatinine \>1.5);
• Cancer involvement of the heart.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego Medical Center

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Anna Narezkina, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: June 12, 2018
• Study Start: January 9, 2018
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)