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

Primary Purpose

Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low dose CT
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Diego Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT monitoring arm

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in CT-based left ventricular strain parameters
Change in CT-based left ventricular strain parameters before and after the chemotherapy
Change in left ventricular global longitudinal strain based on echocardiography
Change in left ventricular global longitudinal strain between baseline and post-chemotherapy.
Change in echocardiographic left ventricular ejection fraction
left ventricular ejection fraction change between baseline and post-chemotherapy.

Full Information

First Posted
January 24, 2018
Last Updated
November 1, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03553654
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
December 12, 2021 (Actual)
Study Completion Date
December 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT monitoring arm
Arm Type
Experimental
Arm Description
18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.
Intervention Type
Diagnostic Test
Intervention Name(s)
low dose CT
Intervention Description
CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages
Primary Outcome Measure Information:
Title
cardiomyopathy
Description
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).
Time Frame
12 months after completion of chemotherapy
Secondary Outcome Measure Information:
Title
Change in CT-based left ventricular strain parameters
Description
Change in CT-based left ventricular strain parameters before and after the chemotherapy
Time Frame
12 months after completion of chemotherapy
Title
Change in left ventricular global longitudinal strain based on echocardiography
Description
Change in left ventricular global longitudinal strain between baseline and post-chemotherapy.
Time Frame
12 months after completion of chemotherapy
Title
Change in echocardiographic left ventricular ejection fraction
Description
left ventricular ejection fraction change between baseline and post-chemotherapy.
Time Frame
12 months after completion of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent. 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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Narezkina, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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