Summary

for people ages 18-75 (full criteria)
at San Diego, California
study started
estimated completion
Anna Narezkina, MD

Description

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.

Keywords

Neoplasms Cardiotoxicity low dose CT

Eligibility

You can join if…

Open to people ages 18-75

  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)
  • Women of child-bearing potential must have a negative pregnancy test during the screening period.

You CAN'T join if...

  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.

Location

  • University of California San Diego Medical Center accepting new patients
    San Diego California 92037 United States

Lead Scientist

  • Anna Narezkina, MD
    Assistant Clinical Professor, Medicine. Authored (or co-authored) 6 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03553654
Study Type
Interventional
Last Updated