Primary Aldosteronism Clinical Trial
Official title:
A Phase 1 Clinical Trial Evaluating the Safety and Efficacy of up to Two Administrations of the Adrenal PET Tracer [18F]CETO in Healthy Volunteers and Patients With Primary Aldosteronism
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).
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.
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