Primary hyperaldosteronism - Conn's syndrome and bilateral adrenal hyperplasia. Imaging of adrenal lesions using 11C-metomidate PET. Pre-suppression with dexamethasone and/or fludrocortisone to optimise scan.
Conditions
Interventions
Trade Name: No trade name (generic name dexamethasone)
Product Name: dexamethasone
Pharmaceutical Form: Tablet
Trade Name: Florinef (fludrocortisone)
Pharmaceutical Form: Tablet
Product Name: 11C-me
Sponsors
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female Age >=18yrs Suspected Conn's syndrome (hypertension BP>140/90mmHg, plasma aldosterone >400pmol/L, raised aldosterone:renin ratio, hypokalaemia, Na+ >140mmol/L, metabolic alkalosis, likely adenoma on CT/MR imaging of adrenal glands) Suspected bilateral adrenal hyperplasia (evidence of hyperaldosteronism, bilateral adrenal enlargement on CT/MR imaging of adrenal glands and failure of lateralisation of aldosterone secretion on adrenal venous sampling) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Inability to give informed consent Heart failure (risk of worsening of condition with fludrocortisone administration)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to determine whether 11C-metomidate PET scanning (a type of scan of the adrenal glands) is as good as the standard procedure of adrenal venous sampling (where blood is taken from within the adrenal veins) at lateralising Conn's adenoma (a tumour of the adrenal gland that causes high blood pressure) and whether uptake of 11C-metomidate into the tumour can be increased by giving drugs (dexamethasone and/or fludrocortisone) before the scan that suppress the uptake of 11C-metomidate into the normal adrenal glands.;Secondary Objective: To evaluate the usefulness of 11C-metomidate PET scanning in a group of patients with bilateral adrenal hyperplasia (a condition in which both adrenals are overactive and produce too much aldosterone hormone).;Primary end point(s): The sensitivity of 11C-metomidate PET scanning for detecting Conn's adenoma. | — |
Countries
United Kingdom
Outcome results
None listed