A study to identify increased production of aldosterone by the adrenal gland using PET/CT scanning techniques
| ISRCTN | ISRCTN58338025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58338025 |
| IRAS number | 274695 |
| Secondary identifying numbers | CPMS 49883, IRAS 274695 |
- Submission date
- 14/06/2022
- Registration date
- 22/07/2022
- Last edited
- 11/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
One of the most common causes of high blood pressure is primary hyperaldosteronism (PHA), a hormonal disorder that leads to overproduction of a hormone called aldosterone. Aldosterone usually balances sodium and potassium in the blood, however when too much of this hormone is produced more potassium is lost but the body retains the sodium. This imbalance can cause your body to hold too much water which in turn leads to a greater volume of blood and ultimately increased blood pressure.
One of the causes of PHA is a non-cancerous tumour that grows on the gland that produces aldosterone In these cases surgery to remove these glands can substantially reduce blood pressure and medication requirements and may result in a complete cure (30-60% of cases).
Currently, methods of diagnosis for this tumour are inefficient and often inconclusive; screening, such as CT scans and adrenal vein sampling (AVS) is used. AVS is challenging, invasive, has a poor success rate and is often not feasible as it requires patients with high blood pressure to stop medication for several weeks.
We have developed a molecule that will target an enzyme which acts as the main regulator of aldosterone secretion. It is labelled with a radioactive substance that Is regularly used in PET scanning. Patients with increased levels of this enzyme from the adrenal glands should absorb more of the molecule. As the molecule is radioactive, this will be detected by a Positron Emission Tomography/Computed Tomography (PET/CT) scanner and can be viewed by a radiologist.
We have trialled this in animals and found that the radiolabelled substance does target expression of the correct enzyme and can be given in quantities that should not be harmful to humans.
We would like to use this tracer in patients that have an aldosterone producing tumour, to illustrate this effect in humans, and as the patients will go on to have surgery we can examine the adrenal tissue that has been removed to confirm that enzyme expression is related to uptake of the tracer.
Study Aims
1. To measure aldosterone synthase (the enzyme known as CYP11B2) levels in vivo
2. To make a preliminary analysis of the relationship between aldosterone production in vivo (as determined by adrenal vein sampling) and levels of aldosterone synthase (measured with PET).
Who can participate?
Patients that are due to have surgical resection of their unilateral adenoma will be eligible.
What does the study involve?
The primary activity for participants is to undergo PET/CT scan procedure following an injection of 18F-UCB2 which will take around 90 minutes.
What are the possible benefits and risks of participating?
There is a small risk associated with exposure to radioactivity, which has been assessed and deemed as acceptable.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
October 2021 to August 2023
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Prof Erik Arstad, e.arstad@ucl.ac.uk
Contact information
Principal Investigator
Centre for Radiopharmaceutical Chemistry (CRC)
Kathleen Lonsdale Building
room 2.08 A
5 Gower Place
London
WC1E 6BT
WC1E 6BS
United Kingdom
| Phone | +44 (0)20 7679 2344 |
|---|---|
| Uclh.randd@nhs.net |
Public
University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom
| robertshortman@nhs.net |
Study information
| Study design | Prospective mechanistic cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact detials to request a particpant information sheet. |
| Scientific title | Image-Derived Enzymatic Adrenal Lateralisation of Primary Aldosteronism |
| Study acronym | IDEAL |
| Study objectives | The use of a radiolabelled inhibitor of aldosterone synthase in combination with PET/CT scanning could elucidate assymetric uptake between adrenal glands, indicating presence of an aldosterone producing adenoma (APA). |
| Ethics approval(s) | Approved 11/10/2021, London - Brent Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; brent.rec@hra.nhs.uk), ref: 21/LO/0521 |
| Health condition(s) or problem(s) studied | Aldosterone producing adenoma |
| Intervention | The first four patients enrolled will undergo a 90 minute scan including dynamic injection of 18F-UCB2 in order to identify the optimal imaging time point for scanning. The second four patients will undergo the same procedure divided into separate imaging acquisitions in order to understand the biodistribution and dosimetry of the tracer. The third group will be scanned at the pre-determined optimal fixed time frame as determined for Objective A, and the tracer uptake will be determined by standardized uptake values (SUVs). There will be no difference between participants in terms of eligibility, and will be included by order of identification. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Uptake of 18F-UCB2 by the adrenal glands measured using PET/CT scanning techniques following identification, and prior to surgery for adrenalectomy |
| Secondary outcome measures | Levels of aldosterone synthase identified post operatively in resected adrenals |
| Overall study start date | 11/10/2021 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 17 |
| Key inclusion criteria | Patients with a diagnosis of, and planned surgery for aldosternone producing adnemoma |
| Key exclusion criteria | Inability to understand, or insufficient capacity to give informed consent. |
| Date of first enrolment | 04/01/2022 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
250 Euston Road
London
NW1 2PG
NW1 2PG
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0) 20 7679 2000 |
|---|---|
| e.arstad@ucl.acuk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Abstract results | Society for Endocrinology BES 2023 | 15/11/2023 | 11/04/2024 | No | No |
| Plain English results | 09/05/2025 | 11/06/2025 | No | Yes |
Additional files
Editorial Notes
11/06/2025: A file of plain English results was uploaded as an additional file.
11/04/2024: Abstract added.
09/04/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. A contact was added.
18/09/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/08/2023 to 30/04/2024.
2. The overall study end date was changed from 31/08/2023 to 30/04/2024.
04/08/2022: Internal review.
15/06/2022: Trial's existence confirmed by Medical Research Council
