Can an MRI scan show early signs of medication-related changes to the heart in patients with breast cancer treated with trastuzumab?

Recruiting

• Conditions: Trastuzumab-associated cardiomyopathy; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN83167415
• Lead Sponsor: Working Group Cardiac MRI @ Charité University Medicine Berlin & HELIOS Hospital Berlin-Buch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 14 January 2019
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Mammary carcinoma
2. Planned trastuzumab therapy

Exclusion Criteria

1. Any absolute contraindication for MRI
2. Chronic renal failure with GFR <30 ml/min/m2 at time of inclusion

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean native myocardial T1 time measured using MRI (MOLLI sequences) at all time points (before start of chemotherapy, before the first dose of trastuzumab, before the second dose of trastuzumab and after 5 cycles of trastuzumab)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Left ventricular ejection fraction<br> 2. Myocardial T2 time<br> 3. Late gadolinium enhancement<br> 4. Longitudinal strain<br> 5. Circumferential strain<br> All secondary outcome measures are assessed using MRI at all time points (before start of chemotherapy, before the first dose of trastuzumab, before the second dose of trastuzumab and after 5 cycles of trastuzumab).<br>