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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• For patients with primary aldosteronism (PA\_CURE 2 / PA\_MTO EH):

‣ 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)

⁃ Keen for surgical treatment if shown to have unilateral adrenal disease.

• For patients with suspected adrenal tumors (PA\_MTO AT)

‣ All patients with suspected adrenal tumors based on imaging and clinical suspicion.

Locations
Other Locations
Singapore
Changi General Hospital
RECRUITING
Singapore
Khoo Teck Puat Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Ng Teng Fong General Hospital
RECRUITING
Singapore
Sengkang General Hospital
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Contact Information
Primary
Troy Puar Hai Kiat, MRCP, PHD
troy.puar.h.k@singhealth.com.sg
64267818
Backup
Geraldine Lim
geraldine.lim.x@singhealth.com.sg
64267818
Time Frame
Start Date: 2019-12-30
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 100
Treatments
Experimental: 11C-metomidate PET-CT
All patients will undergo standard-of-care investigations (CT imaging of adrenals and AVS) and the research test (11C-metomidate PET-CT) with a dose of 100 - 300 Megabecquerel (MBq) (11C-metomidate) to identify functional unilateral adrenal disease
Sponsors
Collaborators: Sengkang General Hospital, Singapore General Hospital, Khoo Teck Puat Hospital, Clinical Imaging Research Centre, Ng Teng Fong General Hospital, National University Health System, Singapore, Tan Tock Seng Hospital
Leads: Changi General Hospital

This content was sourced from clinicaltrials.gov

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