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

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)

Conditions

• Primary Aldosteronism Due to Aldosterone Producing Adenoma
• Primary Aldosteronism
• Adrenal Tumors

Interventions

COMBINATION_PRODUCT

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

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

Sponsors & Collaborators

• National University Health System, Singapore

  collaborator OTHER

• Clinical Imaging Research Centre

  collaborator UNKNOWN

• Singapore General Hospital

  collaborator OTHER

• Tan Tock Seng Hospital

  collaborator OTHER

• Khoo Teck Puat Hospital

  collaborator OTHER

• Ng Teng Fong General Hospital

  collaborator OTHER

• Sengkang General Hospital

  collaborator OTHER

• Changi General Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-30

Primary Completion

2025-05-25

Completion

2025-12-31

Countries

• Singapore

Study Locations