Ignite Creation Date:
2025-12-25 @ 4:38 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT04529018
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2020-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CETO First in Human Trial
Sponsor:
University of Cambridge
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CETO
Brief 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).
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: