Clinical trial NCT03990701: Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
Official title: Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Primary Aldosteronism
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Keywords: 11-C Metomidate PET/CT
Hypertension
Adrenalectomy
Adrenal Vein Sampling
Subtyping
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: National University Health System, Singapore
name: Clinical Imaging Research Centre
name: Singapore General Hospital
name: Tan Tock Seng Hospital
name: Khoo Teck Puat Hospital
name: Ng Teng Fong General Hospital
First posted: 2019-06-19
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

• 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cure of Primary Aldosteronism Post-Adrenalectomy
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Diagnosis of Unilateral Primary Aldosteronism
timeFrame: 6 months
measure: Cost-Effectiveness of Diagnostic Test
timeFrame: 6 months
Other outcomes:
measure: Diagnostic criteria using 11C-Metomidate PET/CT
timeFrame: 6 months
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References:
citation: Puar 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.