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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03990701
Other study ID # PA_CURE
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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