11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours

Primary Aldosteronism Clinical Trial

Official title: 11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours

Status Recruiting

Clinical Trial Summary

• 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)

Clinical Trial Description

• The investigators aim to recruit 100 patients with confirmed, or likely, primary aldosteronism to undergo conventional tests, CT, AVS, and 11C-metomidate PET-CT.

• Results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral PA or adrenal tumor will be offered surgery. Patients will be reviewed 6 months post-surgery.

• In a separate study, the investigators will recruit 10 patients with adrenal tumors to differentiate adrenocortical lesions from other lesions in patients with adrenal tumors ;

Related Conditions & MeSH terms

• Adenoma
• Adrenal Gland Neoplasms
• Adrenal Tumors
• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism
• Primary Aldosteronism Due to Aldosterone Producing Adenoma

• NCT number: NCT06100367
• Study type: Interventional
• Source: Changi General Hospital
• Contact: Troy Puar Hai Kiat, MRCP, PHD
• Phone: 64267818
• Email: troy.puar.h.k@singhealth.com.sg
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 30, 2019
• Completion date: July 31, 2025