Cardiac sympathetic innervation imaging in patients with trastuzumab induced cardiotoxicity
- Conditions
- Trastuzumab induced cardiotoxicity1001928010006291
- Registration Number
- NL-OMON34705
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
•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
•WHO 0-2
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
•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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this pilot study is to assess the neuroadrenergic<br /><br>system in patients with cardiac toxicity due to trastuzumab in order to reveal<br /><br>the pathofysiological mechanisms of trastuzumab induced cardiotoxicity</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this study is, in case of a positive tendens of<br /><br>abnormal I-MIBG scans in patients with declined LEVFs, to set up a prospective<br /><br>randomized controlled trial for patients with trastuzumab induced cardiotoxiciy<br /><br>in the future. </p><br>