Primary AldosteronismCETONCT04529018
CETO First in Human Trial
A study testing [18F]CETO in people with Primary Aldosteronism, run by University of Cambridge at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- [18F]CETO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- All participants:
- allergy to radiographic contrast agents
- allergy or contraindication to synacthen
- pregnancy, breastfeeding, or the intention to become pregnant during the 6 months following trial participation
- positive pregnancy test at the screening or baseline visits
- assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.
Show all 17Show fewer
- receipt of another IMP as part of a CTIMP
- prior radiation exposure as part of previous research studies
- recreational drug use, or substance/alcohol dependency
- clinically abnormal screening blood tests.
- Additional exclusion criteria for healthy volunteers:
- women of child-bearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
- exposure to radiation during their work
- received more than 10 mSv of radioactivity in the past 12 months
- any subject with a history of adrenal disease or who, at the screening visit, reports symptoms, or exhibits physical signs, that could be consistent with previously unsuspected adrenal disease
- Additional exclusion criteria for patients:
- allergy or contraindication to dexamethasone treatment (or lactose intolerant)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke' Hospital
Cambridge, Cambridgeshire, CB20QQ
Mark Gurnell, FRCP, PhD, 01223 348739, mg299@medschl.cam.ac.uk
Martin Thomas, PhD, 01223 254 920, martin.thomas@addenbrookes.nhs.uk
About this study
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).
Read the 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.
- Conditions
- Primary Aldosteronism
- Being tested
- [18F]CETO
- Keywords
- Adrenal, Conn's, Endocrine, Aldosterone
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]CETOCombination product
Also called CETO
[18F]CETO is a PET radiotracer used to diagnose and visualise the cause(s) of primary aldosteronism
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | A group of 5 healthy volunteers will be tested with the PET radiotracer [18F]CETO to assess safety of tracer administration, and evaluate uptake by the normal adrenal glands. Receives: Combination Product: [18F]CETO |
| Patients with primary aldosteronism | Experimental | A group of 6 patients with Primary Aldosteronism (3 with unilateral and 3 with bilateral disease) will be tested with up to two administrations of the PET radiotracer [18F]CETO, to assess safety of tracer administration, evaluate the ability of [18F]CETO to distinguish between unilateral and bilateral cases of PA, and determine the effect of Dexamethasone in improving the quality of PET-CT images acquired following administration. Receives: Combination Product: [18F]CETO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of [18F]CETO administration
The primary outcome measure is the overall safety of [18F]CETO. This will be assessed according to the frequency of adverse events, serious adverse events, clinically significant changes in vital signs, ECG and laboratory parameters.
Measured: 6 months
Secondary outcomes (2)
[18F]CETO uptake by the the adrenal glands.
[18F]CETO uptake by the adrenal glands will be assessed by measurement of Standardized Uptake Values (SUV) over the left and right adrenal glands. All assessments will be performed by a dedicated blinded reviewer.
Measured: 6 months
To evaluate uptake in bilateral versus unilateral cases of PA following [18F]CETO administration in up to 6 patients.
Evaluation of adrenal uptake of [18F]CETO in bilateral versus unilateral cases of PA will be performed by comparing SUV values of both adrenal glands in three patients with each subtype of PA (using a dedicated blinded reviewer).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start3 Aug 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Phase I single-centre, open-label, micro-dosing study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Professor Mark Gurnell, University of Cambridge
- Investigators
- Mark Gurnell, PhD, FRCP, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529018
- Sponsor's protocol ID
- CETO-FIH
- Other IDs
- 2018-004851-18, ISRCTN16159564, 2018
- Acronym
- CETO
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burton TJ, Mackenzie IS, Balan K, Koo B, Bird N, Soloviev DV, Azizan EA, Aigbirhio F, Gurnell M, Brown MJ. Evaluation of the sensitivity and specificity of (11)C-metomidate positron emission tomography (PET)-CT for lateralizing aldosterone secretion by Conn's adenomas. J Clin Endocrinol Metab. 2012 Jan;97(1):100-9. doi: 10.1210/jc.2011-1537. Epub 2011 Nov 23.
PubMed 22112805Hahner S, Stuermer A, Kreissl M, Reiners C, Fassnacht M, Haenscheid H, Beuschlein F, Zink M, Lang K, Allolio B, Schirbel A. [123 I]Iodometomidate for molecular imaging of adrenocortical cytochrome P450 family 11B enzymes. J Clin Endocrinol Metab. 2008 Jun;93(6):2358-65. doi: 10.1210/jc.2008-0050. Epub 2008 Apr 8.
PubMed 18397978Bergstrom M, Juhlin C, Bonasera TA, Sundin A, Rastad J, Akerstrom G, Langstrom B. PET imaging of adrenal cortical tumors with the 11beta-hydroxylase tracer 11C-metomidate. J Nucl Med. 2000 Feb;41(2):275-82.
PubMed 10688111Gillett D, Senanayake R, MacFarlane J, Bashari W, Palma A, Hu L, Harper I, Mendichovszky IA, Antoni G, Hellman P, Sundin A, Hird M, Boros I, Brown MJ, Cheow H, Aloj L, Aigbirhio F, Gurnell M. A Phase I/IIa Clinical Trial to Evaluate Safety and Adrenal Uptake of Para-Chloro-2-[18F]Fluoroethyletomidate in Healthy Volunteers and Patients with Primary Aldosteronism. J Nucl Med. 2025 Mar 3;66(3):434-440. doi: 10.2967/jnumed.124.268425.
PubMed 39884776
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04529018
- Acronym / sponsor ID
- CETO / CETO-FIH
- Conditions
- Primary Aldosteronism
- Keywords
- Adrenal, Conn's, Endocrine, Aldosterone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I single-centre, open-label, micro-dosing study
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Combination Product: [18F]CETOA group of 5 healthy volunteers will be tested with the PET radiotracer [18F]CETO to assess safety of tracer administration, and evaluate uptake by the normal adrenal glands. |
| Patients with primary aldosteronism | Experimental | Combination Product: [18F]CETOA group of 6 patients with Primary Aldosteronism (3 with unilateral and 3 with bilateral disease) will be tested with up to two administrations of the PET radiotracer [18F]CETO, to assess safety of tracer administration, evaluate the ability of [18F]CETO to distinguish between unilateral and bilateral cases of PA, and determine the effect of Dexamethasone in improving the quality of PET-CT images acquired following administration. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- allergy to radiographic contrast agents
- allergy or contraindication to synacthen
- pregnancy, breastfeeding, or the intention to become pregnant during the 6 months following trial participation
- positive pregnancy test at the screening or baseline visits
- assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]CETOAlso: CETO[18F]CETO is a PET radiotracer used to diagnose and visualise the cause(s) of primary aldosteronism | Combination product | Healthy Volunteers, Patients with primary aldosteronism |
Primary outcome
Safety of [18F]CETO administration
Time frame: 6 months
The primary outcome measure is the overall safety of [18F]CETO. This will be assessed according to the frequency of adverse events, serious adverse events, clinically significant changes in vital signs, ECG and laboratory parameters.
2 secondary outcomes
[18F]CETO uptake by the the adrenal glands.
Time frame: 6 months
To evaluate uptake in bilateral versus unilateral cases of PA following [18F]CETO administration in up to 6 patients.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Background: PubMed 22112805Burton TJ, Mackenzie IS, Balan K, Koo B, Bird N, Soloviev DV, Azizan EA, Aigbirhio F, Gurnell M, Brown MJ. Evaluation of the sensitivity and specificity of (11)C-metomidate positron emission tomography (PET)-CT for lateralizing aldosterone secretion by Conn's adenomas. J Clin Endocrinol Metab. 2012 Jan;97(1):100-9. doi: 10.1210/jc.2011-1537. Epub 2011 Nov 23.
- Background: PubMed 18397978Hahner S, Stuermer A, Kreissl M, Reiners C, Fassnacht M, Haenscheid H, Beuschlein F, Zink M, Lang K, Allolio B, Schirbel A. [123 I]Iodometomidate for molecular imaging of adrenocortical cytochrome P450 family 11B enzymes. J Clin Endocrinol Metab. 2008 Jun;93(6):2358-65. doi: 10.1210/jc.2008-0050. Epub 2008 Apr 8.
- Background: PubMed 10688111Bergstrom M, Juhlin C, Bonasera TA, Sundin A, Rastad J, Akerstrom G, Langstrom B. PET imaging of adrenal cortical tumors with the 11beta-hydroxylase tracer 11C-metomidate. J Nucl Med. 2000 Feb;41(2):275-82.
- Derived from this study: PubMed 39884776Gillett D, Senanayake R, MacFarlane J, Bashari W, Palma A, Hu L, Harper I, Mendichovszky IA, Antoni G, Hellman P, Sundin A, Hird M, Boros I, Brown MJ, Cheow H, Aloj L, Aigbirhio F, Gurnell M. A Phase I/IIa Clinical Trial to Evaluate Safety and Adrenal Uptake of Para-Chloro-2-[18F]Fluoroethyletomidate in Healthy Volunteers and Patients with Primary Aldosteronism. J Nucl Med. 2025 Mar 3;66(3):434-440. doi: 10.2967/jnumed.124.268425.
- Individual participant dataSharing planned: No
Related trials for Primary Aldosteronism
RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Adrenal Gland Neoplasm, Hypertension
Recruiting
[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
Primary Aldosteronism
Recruiting
Comparing Inclisiran Versus Statin for Primary Aldosteronism
Primary Aldosteronism
Active, not recruitingPhase 3
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
Primary Hyperaldosteronism
RecruitingPhase 4
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Primary Aldosteronism, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Gurnell, PhD, FRCP principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]CETO in people with Primary Aldosteronism, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Thomas, PhD (01223 254 920, martin.thomas@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of [18F]CETO administration (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529018, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.