Summary

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

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03553654
Lead Scientist
Anna Narezkina
Study Type
Interventional
Last Updated
May 30, 2018