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

Prediction of trastuzumab-associated cardiomyopathy using cardiovascular MRI

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN83167415

Enrollment

Registered

2018-11-23

Start date

2018-11-30

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trastuzumab-associated cardiomyopathy Injury, Occupational Diseases, Poisoning

Interventions

Participants receive a maximum of four cardiac MRIs. One MRI before start of chemotherapy (which typically happens before start of trastuzumab), one MRI directly before start of trastuzumab, one MRI d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Mammary carcinoma 2. Planned trastuzumab therapy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Left ventricular ejection fraction 2. Myocardial T2 time 3. Late gadolinium enhancement 4. Longitudinal strain 5. Circumferential strain 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).	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026