Clinical Trials Logo

Clinical Trial Summary

The study is a Phase 1, single-centre, open label, micro-dosing study. The aim is to investigate an innovative new tracer, [18F]CETO, as a potential alternative to adrenal vein sampling for the lateralisation of primary aldosteronism (PA).


Clinical Trial Description

At least one-quarter of the UK adult population has hypertension, a major risk factor for heart attacks and stroke. Primary aldosteronism (PA), a treatable form of hypertension, accounts for 5-10% of all cases, and 20-25% of difficult to control hypertension. It is challenging to determine whether one adrenal gland is the source of PA (which is potentially curable with surgery) or both glands (which would require long-term drug treatment). Existing lateralising procedures (i.e. investigations to distinguish one from two gland involvement e.g. CT or MRI scan) have significant limitations. Accordingly, most patients must undergo an invasive procedure called adrenal vein sampling (AVS) in which small catheters are placed in each adrenal vein. However, this is time-consuming, technically demanding, and fails in 20-50% of cases. To address this, researchers have adopted a novel approach using PET-CT as an alternative to AVS. Currently, this uses a tracer called metomidate labelled with carbon-11 (11C MTO), which is taken up preferentially by the adrenal gland, and in particular by adrenal tumours causing PA. However, its utility is limited by a short half-life, which means the scan can only be performed in centres with a cyclotron facility (currently less than 10 NHS sites). The aim of this study is to investigate the safety of a new tracer with a longer half-life, [18F]CETO, that could be made available for use in many more centres.

The trial objectives are outlined below:

Primary Objective

To evaluate the safety of up to two administrations of [18F]CETO in up to 6 patients with primary aldosteronism and 5 healthy volunteers.

Secondary Objective

- Assess [18F]CETO uptake by the adrenal glands

- Evaluate uptake in bilateral vs unilateral cases of PA following [18F]CETO administration in up to 6 patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04529018
Study type Interventional
Source University of Cambridge
Contact Martin Thomas, PhD
Phone 01223 254 920
Email martin.thomas@addenbrookes.nhs.uk
Status Recruiting
Phase N/A
Start date August 3, 2020
Completion date November 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT02885662 - Study of CS-3150 in Patients With Primary Aldosteronism N/A
Withdrawn NCT02096939 - Microvascular Function in Primary Aldosteronism N/A
Completed NCT01728493 - Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment N/A
Recruiting NCT06228677 - Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization
Recruiting NCT06047912 - Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone
Recruiting NCT04991961 - Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism
Recruiting NCT05501080 - The Effect of SAAE on Ventricular Remodeling in PA Patients N/A
Recruiting NCT05405101 - Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA N/A
Recruiting NCT05973604 - Prevalence of Primary Aldosteronism in Atrial Fibrillation
Recruiting NCT05826080 - Effect of Adrenocorticotropic Hormone Stimulation During Adrenal Vein Sampling in Primary Aldosteronism
Completed NCT04179019 - Calcium Channel Blockade in Primary Aldosteronism Phase 2
Completed NCT03500120 - Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism
Recruiting NCT04213963 - Prospective Study on Primary Aldosteronism in Resistant Hypertension
Completed NCT05435703 - Renal Cysts and Primary Aldosteronism
Recruiting NCT02945904 - IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary Hyperaldosteronism
Enrolling by invitation NCT02257450 - Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study N/A
Recruiting NCT05561361 - The Effect of SAAE on Vascular Endothelial Function in PA Patients
Completed NCT03398785 - Adrenal Artery Ablation Treats Primary Aldosteronism Phase 3
Recruiting NCT04428827 - Outcome of Patients With Primary Aldosteronism
Recruiting NCT03224312 - Chongqing Primary Aldosteronism Study