Myocardial effects of interleukin-2 therapy
Research type
Research Study
Full title
Myocardial complications in patients on high dose interleukin-2 therapy assessed by cardiac magnetic resonance – pilot study
IRAS ID
207446
Contact name
Christopher Miller
Contact email
Sponsor organisation
University Hospital of South Manchester
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Interleukin-2 (IL-2) is a substance that stimulates body's immune defences to recognise and destroy cancer cells. It is used in the treatment of a metastatic kidney cancer and a metastatic melanoma (skin cancer). However, IL-2 is known to cause heart inflammation and damage.
Cardiac magnetic resonance (CMR) has been used extensively in viral myocarditis (heart inflammation caused by viruses). However, its utility in heart inflammation caused by IL-2 therapy has not been well studied.
This pilot study will explore the hypothesis that patients undergoing IL-2 therapy for renal cell cancer will exhibit subclinical heart damage and inflammation which can be detected by CMR.
It is an observational study. Ten patients receiving IL-2 therapy will undergo a multiparametric CMR scan in order to answer the following questions:
i. Is there evidence of cardiac functional abnormalities?
ii. Is there evidence of myocardial fibrosis?
iii. Is there evidence of myocardial inflammation?
iv. Is there a relationship between CMR markers and circulating markers of myocardial damage?Additionally, patients with clinically suspected, overt heart inflammation (myocarditis) caused by IL-2 therapy that require CMR scan on clinical grounds, will also be recruited so that their clinical and scan data can be used in the study.
If positive, this data would be used to power an appropriately sized study aiming to determine which patients develop inflammatory cardiac complications of IL-2 therapy
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
16/NW/0559
Date of REC Opinion
26 Aug 2016
REC opinion
Further Information Favourable Opinion