Gadolinium concentrations in healthy volunteers
Research type
Research Study
Full title
Study to establish blood and urine gadolinium concentrations in healthy volunteers
IRAS ID
250499
Contact name
Paul Dargan
Contact email
Sponsor organisation
Guy's & St Thomas' Foundation NHS Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Gadolinium-based contrast agents (GBCAs) have been widely used for decades to enhance the quality of magnetic resonance imaging (MRI) studies and up to 30% of scans today use GBCAs. Despite an overall excellent safety profile, in 2006 it became apparent that GBCA administration was associated with the development of a rare skin disease in patients with severe underlying renal failure. More recently, clinical studies have shown that gadolinium may deposit within brain tissue in individuals with normal renal function following GBCA administration. There has been increasing interest amongst the medical community and in the lay press in whether clinical signs and symptoms may result when this occurs. A number of commercial laboratories measure urine gadolinium concentrations in people who are concerned that they have been exposed to GBCAs. However, there are no published data relating to gadolinium concentrations in blood or urine in healthy individuals making interpretation of these test results difficult. The primary aims of this study are to 1) determine whether healthy individuals who have not received GBCAs have detectable concentrations of gadolinium in their blood and urine, and 2) to develop a ‘reference range’ for gadolinium levels in healthy individuals.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
18/LO/1614
Date of REC Opinion
17 Sep 2018
REC opinion
Favourable Opinion