NL-OMON34705
Completed
N/A
Cardiac sympathetic innervation imaging in patients with trastuzumab induced cardiotoxicity - CARIT
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Trastuzumab induced cardiotoxicity
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 30
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients with confirmed HER\-2 positive breast cancer (immunohistochemistry score 3 or fluorescence in\-situ hybridization positive) who have completed local regional therapy and treatment with trastuzumab or are still on treatment with trastuzumab.
- •Permanent LVEF \<\=50% after treatment with trastuzumab, and/or
- •A permanent relative decrease of \>\=10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or
- •Symptomatic congestive heart failure defined as NYHA class III/IV
- •Age 18\-80 years.
- •Signed informed consent
- •Amendement: Add control group: patients without a permanent relative decrease of \>\=10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or symptomatic congestive heart failure defined as NYHA class III/IV
Exclusion Criteria
- •Pre\-existing cardiac disease such as heart failure, ischemic and valvular heart disease, arrhythmia or poorly controlled hypertension.
- •Concomitant inflammatory disease.
- •Pregnancy/beast feeding.
- •Allergy against radiopharmaceutical (99m Tc\-based tracer) for MUGA scan.
Outcomes
Primary Outcomes
Not specified
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