Primary Aldosteronism Clinical Trial
Official title:
11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours
- 10% of patients with hypertension potentially have the treatable condition - primary aldosteronism (PA). This is caused by either bilateral adrenal disease (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with laparoscopic surgery (adrenalectomy). Current diagnosis of PA includes a screening test with aldosterone-renin ratio, followed by a confirmatory salt loading test (in most patients) to demonstrate unsuppressed aldosterone levels. Of note, some patients with suppressed aldosterone after confirmatory tests (also termed low-renin hypertension) may also have unilateral adrenal tumors. - The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure. An alternative novel imaging, 11C-Metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors which are over-producing aldosterone. It is non-invasive, non-operator-dependent, and potentially may identify more patients with curable unilateral disease. The results from our pilot study in 25 patients with confirmed PA (ClinicalTrials.gov NCT03990701, PA_CURE) showed that 11C-Metomidate PET-CT exhibited comparable performance to AVS in subtyping PA, and this should be validated in a larger study. - In addition, 11C-Metomidate is also able to differentiate adrenocortical lesions in the adrenal gland from other lesions found in adrenal tissue, such as adrenomedullary lesions (e.g. pheochromocytoma). - Hence, the investigators hypothesize that 11C-metomidate PET-CT can accurately (1) identify patients with surgically curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism (PA_CURE 2 / PA_MTO EH study) and (2) differentiate adrenocortical lesions from other lesions in patients with adrenal tumors (PA_MTO AT study)
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | Inclusion Criteria: - For patients with primary aldosteronism (PA_CURE 2 / PA_MTO EH): 1. Confirmed diagnosis of 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; or likely primary aldosteronism / low-renin hypertension (inappropriate aldosterone levels and suppressed renin levels) 2. Keen for surgical treatment if shown to have unilateral adrenal disease. - For patients with suspected adrenal tumors (PA_MTO AT) 1. All patients with suspected adrenal tumors based on imaging and clinical suspicion. Exclusion Criteria: - Inability to provide written informed consent. - Chronic renal failure of Stage 3b or greater severity, estimated glomerular filtration rate (eGFR) < 45ml/min/1.73m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. (only applicable for PA_CURE 2 / PA_MTO EH) - Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure (only applicable for PA_CURE 2 / PA_MTO EH) - Contraindications to isotope scanning (e.g. Female patients who are pregnant (self-declared or via positive pregnancy test), intending to become pregnant (within 3 months of scan) or breastfeeding) or CT Scan, which includes but not limited to waist circumference >140cm, morbid obesity or claustrophobia (limiting entry in CT scanner) - Contraindication to ingestion of corticosteroids (e.g. poorly controlled diabetes, HbA1C >13%) |
Country | Name | City | State |
---|---|---|---|
Singapore | Changi General Hospital | Singapore | |
Singapore | Khoo Teck Puat Hospital | Singapore | |
Singapore | National University Hospital | Singapore | |
Singapore | Ng Teng Fong General Hospital | Singapore | |
Singapore | Sengkang General Hospital | Singapore | |
Singapore | Singapore General Hospital | Singapore | |
Singapore | Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Changi General Hospital | Clinical Imaging Research Centre, Khoo Teck Puat Hospital, National University Health System, Singapore, Ng Teng Fong General Hospital, Sengkang General Hospital, Singapore General Hospital, Tan Tock Seng Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemical outcome of unilateral primary aldosteronism based on the Primary Aldosteronism Surgical Outcome (PASO) criteria (PA_CURE 2 / PA_MTO EH study). | The number of patients with complete, partial, and absent biochemical success according to the PASO criteria. | 6 months | |
Primary | Diagnostic performance of 11C-Metomidate PET-CT in identifying unilateral adrenocortical tumor (PA_MTO AT study). | Percentage of patients accurately identified with adrenocortical tumor using 11C-Metomidate PET-CT, when compared to the histopathology of the excised tumor. In patients who have not undergone surgery, this will be determined by clinical diagnosis. | 6 months | |
Secondary | Clinical outcome of unilateral primary aldosteronism based on the Primary Aldosteronism Surgical Outcome (PASO) criteria (PA_CURE 2 / PA_MTO EH STUDY). | The number of patients with complete, partial, and absent clinical success according to the PASO criteria. | 6 months | |
Secondary | Diagnostic performance of 11C-Metomidate PET-CT in identifying unilateral aldosterone-producing adenoma (PA_CURE 2 / PA_MTO EH study). | Percentage of patients accurately identified with unilateral PA using 11C-Metomidate PET-CT and AVS, as compared to histopathology of the excised tumor (defined as 'Classical' single, functioning aldosterone-producing adenoma using HISTopathological classification by the Histopathology of primary ALDOsteronism (HISTALDO) consensus). | 6 months | |
Secondary | Cost-effectiveness of 11C-Metomidate PET-CT versus AVS in diagnosing patients with unilateral primary aldosteronism (PA_CURE 2 / PA_MTO EH STUDY). | Cost-effectiveness of the diagnostic course will be calculated by using calculated costs per quality-adjusted life years (QALYs). | 6 months | |
Secondary | Diagnostic criteria using 11C-metomidate PET/CT (PA_CURE 2 / PA_MTO EH study). | The cut-off level of maximum standard update value (SUVmax) values which offer the best sensitivity and specificity for lateralization of aldosterone-producing adenoma in 11C-metomidate PET/CT. | 6 months | |
Secondary | Number of patients with low-renin hypertension with unilateral adrenal tumors (PA_CURE 2 / PA_MTO EH study). | Quantify the number of patients with low-renin hypertension or only obtain borderline diagnostic criteria for PA but have unilateral adrenal lesions detected on 11C-metomidate PET/CT. | 6 months |
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