CHARRT
Research type
Research Study
Full title
CHARRT (Carcinoid Heart Disease and Radiotargeted Peptide Receptor Therapy): Pilot randomised trial to assess progression of carcinoid heart disease in patients treated with Lutathera therapy compared to best supportive care.
IRAS ID
263064
Contact name
Rajaventhan Srirajaskanthan
Contact email
Sponsor organisation
Kings College Hospital NHS Foundation Trust
Eudract number
2019-001632-61
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
na, na
Duration of Study in the UK
5 years, 0 months, 6 days
Research summary
Carcinoid heart disease (CHD) is a rare condition that occurs in patients with metastatic neuroendocrine tumours. Its pathophysiology is not well understood however, a hormone called serotonin is thought to be responsible. This hormone is made by a tumour commonly arising from the gastrointestinal tract and leads to a clinical syndrome called carcinoid syndrome. Previous studies have identified that Lutathera delays progression of disease and can lead to a reduction in hormone secretion in carcinoid syndrome.
This is a pilot, randomised, multi-centre trial which aims to determine whether treatment of patients with mild/ moderate CHD with Lutathera therapy will delay further progression of valve disease and possibly improve survival and/or Quality of Life compared to current best supportive care with / without somatostatin analogues (SSTAs - a treatment currently used to slow down the production of hormones in the gut).
20 patients will be recruited in total. 10 patients will be randomly allocated onto the study arm, and will receive 4x doses of Lutathera therapy every 8 weeks, in addition to routine SSTAs. 10 patients will be randomly assigned to the best supportive care arm, and will receive SSTA treatment only.
All 20 participants will be followed-up in clinic every 4-6 months until disease progression (as defined by radiological assessment) or for a maximum of 4 years.
REC name
West of Scotland REC 1
REC reference
22/WS/0012
Date of REC Opinion
28 Apr 2022
REC opinion
Further Information Favourable Opinion