11C metomidate PET scanning for Conn's syndrome

Conditions: 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.

Registration Number: EUCTR2008-000051-10-GB

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Inability to give informed consent
Heart failure (risk of worsening of condition with fludrocortisone administration)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures