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ACTIVE NOT RECRUITING
NCT06100367
PHASE2/PHASE3

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

Sponsor: Changi General Hospital

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2019-12-30

Completion Date

2025-12-31

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre

11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre

Locations (7)

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, Singapore