Predicting outcome from adrenalectomy
Research type
Research Study
Full title
IS Metomidate PET-CT superior to Adrenal venous sampling in predicting ouTCome from adrenalectomy in patients with primary Hyperaldosteronism (MATCH)
IRAS ID
189508
Contact name
Morris Jonathan Brown cc to Coordinator j.salsbury@qmul.ac.uk
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
The primary aim of the multicentre clinical trial is to evaluate two diagnostic procedures, PET CT scan and Adrenal Vein Sampling (AVS), used in the diagnosis of primary hyperaldosteronism (production of too much aldosterone).
It is estimated that 5-10% of patients with hypertension (high blood pressure) may have a curable cause. The commonest curable cause is an aldosterone-producing, benign tumour (adenoma) of the adrenal gland. Aldosterone is known as the ‘salt hormone’ as it retains salt. This increases blood pressure by increasing circulatory volume in blood vessels. This condition is frequently referred to as Primary Hyperaldosteronism (PHA).
PHA is typically due either to a single, benign tumour (adenoma) in one of the adrenal glands (unilateral) or to diffuse ‘overgrowth’ in both adrenal glands (bilateral adrenal hyperplasia BAH). Differentiation between these two causes is crucial as surgical removal of an adenoma producing too much aldosterone often cures PHA, but does not help patients with bilateral BAH. Standard investigations to distinguish between unilateral adenomas and BAH include CT/MRI scanning and adrenal vein sampling (AVS). PET CT, which is CT scanning combined with injection of a short-acting radioactive tracer, is currently available only in a few centres.
If the adenoma is only in one of the adrenal glands (unilateral), it means that the affected gland can be removed by key-hole surgery (laparoscopy). However only about half of the patients having this operation will have their hypertension completely cured. The MATCH study aims to find if there are ways that we can predict who the 50% are that will be cured, so that surgery can be avoided in those who will derive less benefit.
At present, all patients proceeding to adrenalectomy (removal of an adrenal gland) have either one or both of two tests that can diagnose whether the patient has a unilateral cause of their hyperaldosteronism: PET CT or AVS. Surgery is not indicated if both adrenal glands are found to be over-active. Neither of the diagnostic tests are 100% accurate and which test is performed will depend on local expertise and availability, but often both are required before a definitive diagnosis is made.Of the 140 patients enrolled onto the study with a diagnosis of PHA, 6 patients will be a requested to attend for a repeat PET CT scan with a short acting radioactive tracer 6 weeks following spironolactone therapy, which is the licensed medication for PAH. Patients will be managed by a specialist endocrine/hypertension study team of professionals.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1242
Date of REC Opinion
5 Aug 2016
REC opinion
Further Information Favourable Opinion