Primary AldosteronismEarly Phase 1NCT03990701
Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
A Early Phase 1 study testing 11C-Metomidate PET/CT Scan in people with Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Changi General Hospital at 1 site in Singapore.
Trial summary
10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with laparoscopic surgery (adrenalectomy). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma
- What is being tested?
- 11C-Metomidate PET/CT Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- 21 May 2018to 30 Mar 2021
- Phase
- Early Phase 1
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary aldosteronism, as defined in Endocrine Society Guidelines 2016, with positive confirmatory test (post-salt loading aldosterone >140pmol/L); or hypokalemia with undetectable renin levels and aldosterone >550pmol/L.
Who cannot join
- Inability to provide written informed consent
- < 21 years or > 70 years
- Chronic renal failure of Stage 3b or greater severity
- Severe or terminal medical condition(s)
- Contraindications to isotope scanning or CT Scan
- Contraindication to ingestion of corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with laparoscopic surgery (adrenalectomy). Unfortunately, many patients with curable hypertension remain undiagnosed and consequently develop cardiac disease and strokes. The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure, with inconclusive results in 50% of patients. An alternative novel imaging, 11C-metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors, and concurrently confirm their over-activity. It is non-invasive, non-operator-dependent, and can identify more patients with curable hypertension.
Investigators hypothesize that 11C-metomidate PET-CT can accurately identify patients with surgically-curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism.
Read the detailed description
25 patients with confirmed PA who are keen for a surgical cure if unilateral PA is confirmed, will undergo conventional tests, CT, AVS, as well as 11C-metomidate PET/CT.
Results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral PA will be offered surgery. Patients will be reviewed 6 months post surgery to assess for cure of PA.
- Being tested
- 11C-Metomidate PET/CT Scan
- Keywords
- 11-C Metomidate PET/CT, Hypertension, Adrenalectomy, Adrenal Vein Sampling, Subtyping
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-Metomidate PET/CT ScanCombination product
11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients will undergo standard-of-care investigations (CT imaging of adrenals and AVS) and the research test (11C-metomidate PET-CT) with a dose of 150 - 300 Megabecquerel (MBq) (11C-metomidate) to identify functional unilateral adrenal disease. Receives: Combination Product: 11C-Metomidate PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of Primary Aldosteronism Post-Adrenalectomy
Percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using AVS
Measured: 6 months
Secondary outcomes (2)
Clinical Diagnosis of Unilateral Primary Aldosteronism
Percentage of patients accurately identified with unilateral PA (determined by clinical diagnosis made by multidisciplinary team) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by clinical diagnosis made by multidisciplinary team) using AVS
Measured: 6 months
Cost-Effectiveness of Diagnostic Test
Cost-Effectiveness of Diagnostic Test to identify unilateral PA
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 posted19 Jun 2019
- Study start21 May 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 11C-metomidate will be manufactured in Clinical Imaging Research Centre in compliance with good manufacturing practice using a General Electric Medical Systems PET trace 860 cyclotron. Non-contrast CT images will be acquired over the adrenal. After an intravenous injection of 11C-metomidate, PET images will be acquired within the first 45 min. Attenuation and decay-corrected images will be converted to standardized uptake value (SUV) maps through division by (injected activity per patient weight). The maximum SUV values over regions of interest will be determined for 10-min static images starting 35 min after the injection.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University Health System, Singapore, Clinical Imaging Research Centre, Singapore General Hospital, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, Ng Teng Fong General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990701
- Sponsor's protocol ID
- PA_CURE
- Status last verified
- May 2021
- First submitted
- 19 Dec 2018
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
King TFJ, Mok Y, Dacay LM, Wong HS, Hsu PP, Tan A, Wong KM, Saffari SE, Lenders JWM, Puar TH. Plasma Metanephrines Yield Fewer False-Positive Results Than Urine Metanephrines in Patients With Obstructive Sleep Apnea. J Clin Endocrinol Metab. 2024 Feb 20;109(3):844-851. doi: 10.1210/clinem/dgad553.
PubMed 37721483Puar TH, Khoo CM, Tan CJ, Tong AKT, Tan MCS, Teo AE, Ng KS, Wong KM, Reilhac A, O'Doherty J, Gomez-Sanchez CE, Kek PC, Yee S, Tan AWK, Chuah MB, Lee DHM, Wang KW, Zheng CQ, Shi L, Robins EG, Foo RSY; for the PA CURE investigators. 11C-Metomidate PET-CT versus adrenal vein sampling to subtype primary aldosteronism: a prospective clinical trial. J Hypertens. 2022 Jun 1;40(6):1179-1188. doi: 10.1097/HJH.0000000000003132.
PubMed 35703880
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
- ClinicalTrials.gov ID
- NCT03990701
- Acronym / sponsor ID
- PA_CURE
- Keywords
- 11-C Metomidate PET/CT, Hypertension, Adrenalectomy, Adrenal Vein Sampling, Subtyping
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- National University Health System, Singapore, Clinical Imaging Research Centre, Singapore General Hospital, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, Ng Teng Fong General Hospital
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 19 Jun 2019 (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.
10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with laparoscopic surgery (adrenalectomy). Unfortunately, many patients with curable hypertension remain undiagnosed and consequently develop cardiac disease and strokes. The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure, with inconclusive results in 50% of patients. An alternative novel imaging, 11C-metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors, and concurrently confirm their over-activity. It is non-invasive, non-operator-dependent, and can identify more patients with curable hypertension.
Investigators hypothesize that 11C-metomidate PET-CT can accurately identify patients with surgically-curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism.
Detailed description
25 patients with confirmed PA who are keen for a surgical cure if unilateral PA is confirmed, will undergo conventional tests, CT, AVS, as well as 11C-metomidate PET/CT.
Results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral PA will be offered surgery. Patients will be reviewed 6 months post surgery to assess for cure of PA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 11C-metomidate will be manufactured in Clinical Imaging Research Centre in compliance with good manufacturing practice using a General Electric Medical Systems PET trace 860 cyclotron. Non-contrast CT images will be acquired over the adrenal. After an intravenous injection of 11C-metomidate, PET images will be acquired within the first 45 min. Attenuation and decay-corrected images will be converted to standardized uptake value (SUV) maps through division by (injected activity per patient weight). The maximum SUV values over regions of interest will be determined for 10-min static images starting 35 min after the injection.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Combination Product: 11C-Metomidate PET/CT ScanAll patients will undergo standard-of-care investigations (CT imaging of adrenals and AVS) and the research test (11C-metomidate PET-CT) with a dose of 150 - 300 Megabecquerel (MBq) (11C-metomidate) to identify functional unilateral adrenal disease. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary aldosteronism, as defined in Endocrine Society Guidelines 2016, with positive confirmatory test (post-salt loading aldosterone >140pmol/L); or hypokalemia with undetectable renin levels and aldosterone >550pmol/L.
Key exclusion criteria (6 listed)
- Inability to provide written informed consent
- < 21 years or > 70 years
- Chronic renal failure of Stage 3b or greater severity
- Severe or terminal medical condition(s)
- Contraindications to isotope scanning or CT Scan
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 |
|---|---|---|
| 11C-Metomidate PET/CT Scan11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre | Combination product | Single Arm |
Primary outcome
Cure of Primary Aldosteronism Post-Adrenalectomy
Time frame: 6 months
Percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using AVS
2 secondary outcomes
Clinical Diagnosis of Unilateral Primary Aldosteronism
Time frame: 6 months
Cost-Effectiveness of Diagnostic Test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 37721483King TFJ, Mok Y, Dacay LM, Wong HS, Hsu PP, Tan A, Wong KM, Saffari SE, Lenders JWM, Puar TH. Plasma Metanephrines Yield Fewer False-Positive Results Than Urine Metanephrines in Patients With Obstructive Sleep Apnea. J Clin Endocrinol Metab. 2024 Feb 20;109(3):844-851. doi: 10.1210/clinem/dgad553.
- Derived from this study: PubMed 35703880Puar TH, Khoo CM, Tan CJ, Tong AKT, Tan MCS, Teo AE, Ng KS, Wong KM, Reilhac A, O'Doherty J, Gomez-Sanchez CE, Kek PC, Yee S, Tan AWK, Chuah MB, Lee DHM, Wang KW, Zheng CQ, Shi L, Robins EG, Foo RSY; for the PA CURE investigators. 11C-Metomidate PET-CT versus adrenal vein sampling to subtype primary aldosteronism: a prospective clinical trial. J Hypertens. 2022 Jun 1;40(6):1179-1188. doi: 10.1097/HJH.0000000000003132.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 11C-Metomidate PET/CT Scan in people with Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Changi General Hospital at 1 site in Singapore.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 1 Jun 2021. 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 Singapore. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure of Primary Aldosteronism Post-Adrenalectomy (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 NCT03990701, which also lists 2 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 1 Jun 2021.