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

Launched by CHANGI GENERAL HOSPITAL · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called 11C-Metomidate PET/CT, which aims to help doctors identify a specific type of high blood pressure known as primary aldosteronism (PA). About 10% of people with high blood pressure may have this condition, which can sometimes be treated with surgery if it is due to a single tumor in the adrenal gland. The goal of the trial is to see if this new imaging method can accurately find patients with surgically treatable adrenal tumors and to distinguish between different types of adrenal lesions. This could make it easier for patients to receive the appropriate treatment.

To be eligible for this trial, participants should have a confirmed diagnosis of primary aldosteronism and be interested in surgical treatment if they have a tumor. The trial is open to adults aged 18 to 80, regardless of gender. Participants will undergo the non-invasive PET/CT scan and may have the chance to receive better-targeted care based on the results. It’s important to know that some people may not be able to participate due to certain health conditions or if they are pregnant or breastfeeding. If you're interested in learning more or think you might qualify, please talk to your doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * For patients with primary aldosteronism (PA_CURE 2 / PA_MTO EH):
• • 1. 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)
• • 2. Keen for surgical treatment if shown to have unilateral adrenal disease.
• • For patients with suspected adrenal tumors (PA_MTO AT)
• • 1. 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%)