Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate

Primary Aldosteronism Clinical Trial

Official title:

Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990701
• Other study ID #: PA_CURE
• Status: Completed
• Phase: Early Phase 1
• Start date: May 21, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: May 2021
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism
• Primary Aldosteronism Due to Aldosterone Producing Adenoma

Intervention

Combination Product:
• 11C-Metomidate PET/CT Scan
11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (7)

Lead Sponsor	Collaborator
Changi General Hospital	Clinical Imaging Research Centre, Khoo Teck Puat Hospital, National University Health System, Singapore, Ng Teng Fong General Hospital, Singapore General Hospital, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic criteria using 11C-Metomidate PET/CT	To assess the cut-off level of SUVmax which offers the best sensitivity and specificity for lateralisation in 11C-metomidate PET-CT	6 months
Primary	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	6 months
Secondary	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	6 months
Secondary	Cost-Effectiveness of Diagnostic Test	Cost-Effectiveness of Diagnostic Test to identify unilateral PA	6 months