Scleroderma Heart Study
Research type
Research Study
Full title
A study of use of 18FDG-PET-CT scanning to define presence of inflammation in scleroderma myocardial involvement
IRAS ID
186226
Contact name
Benjamin Schreiber
Contact email
Sponsor organisation
Royal Free Hospital
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Scleroderma is a rare disease affecting a few thousand patients in the UK. The cause is not known. Patients develop fibrosis – a kind of scar tissue – in the skin, making it tight and hard. Internal organs are often affected too, including the lungs, kidney and bowel. Scleroderma can affect the heart, which can be mild or severe and devastating. Because this complication is uncommon, little is known about how best to diagnose and treat this condition. Current practice is to use MRI scans and sometimes biopsies of the heart to make a diagnosis of scleroderma heart involvement. Treatment is often with drugs to suppress the immune system. However, it is not known how much inflammation there is in the heart in patients with scleroderma, nor whether the treatment might work to suppress that inflammation.
In this pilot study, based in a national centre for scleroderma patients, we plan to perform PET-CT scans on patients who we suspect have heart involvement from their scleroderma. This scan is already widely used in patients with cancer and in some other conditions. It involves the injection into a regular vein of sugar with a tracer attached to it, so the scan can track where the sugar is taken up. This may enable us to assess whether there is active inflammation within the heart in these patients. The scan will be done alongside their standard care, allowing us to compare findings on PET-CT to findings on standard procedures including echocardiograms, MRI scans and cardiac biopsy. Furthermore, if patients have evidence of inflammation within the heart, repeating the scan after a few months of therapy to suppress the immune system may show whether we have been successful in reducing the inflammation within the heart.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0292
Date of REC Opinion
29 Aug 2016
REC opinion
Further Information Favourable Opinion