11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours
Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism, Adrenal Tumors
About this trial
This is an interventional diagnostic trial for Primary Aldosteronism Due to Aldosterone Producing Adenoma focused on measuring 11-C Metomidate PET/CT, Functional imaging, Secondary / Endocrine hypertension, Adrenal Vein Sampling, Subtyping; localization testing, Adrenalectomy
Eligibility Criteria
Inclusion Criteria: 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. 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%)
Sites / Locations
- Changi General HospitalRecruiting
- Khoo Teck Puat HospitalRecruiting
- National University HospitalRecruiting
- Ng Teng Fong General HospitalRecruiting
- Sengkang General HospitalRecruiting
- Singapore General HospitalRecruiting
- Tan Tock Seng HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Experimental: Single Arm
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