Using 11C-Metomidate PET/CT to identify adrenal tumors in patients with hypertension
11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours
This study is testing if a special type of imaging called 11C-Metomidate PET/CT can help find adrenal tumors in people with high blood pressure caused by excess aldosterone.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Changi General Hospital Academic / other |
| Locations | 7 sites (Singapore and 6 other locations) |
| Trial ID | NCT06100367 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to recruit 100 patients diagnosed with primary aldosteronism to evaluate the effectiveness of 11C-Metomidate PET/CT imaging in identifying adrenal tumors that produce excess aldosterone. Participants will undergo conventional diagnostic tests, including CT scans and adrenal vein sampling, alongside the novel PET/CT imaging. The results will be discussed in a multidisciplinary meeting, and those with unilateral adrenal disease may be offered surgical intervention. Additionally, a separate group of 10 patients with adrenal tumors will be assessed to differentiate between adrenocortical lesions and other types of lesions.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed or suspected primary aldosteronism and those with suspected adrenal tumors based on imaging.
Not a fit: Patients with chronic renal failure of Stage 3b or greater severity will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for accurately diagnosing adrenal tumors, leading to more effective treatment options for patients with primary aldosteronism.
How similar studies have performed: While the use of 11C-Metomidate PET/CT is a novel approach, similar imaging techniques have shown promise in other studies for diagnosing adrenal conditions.
Eligibility criteria
Show full inclusion / exclusion 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%)
Where this trial is running
Singapore and 6 other locations
- Changi General Hospital — Singapore, Singapore (Recruiting)
- Khoo Teck Puat Hospital — Singapore, Singapore (Recruiting)
- National University Hospital — Singapore, Singapore (Recruiting)
- Ng Teng Fong General Hospital — Singapore, Singapore (Recruiting)
- Sengkang General Hospital — Singapore, Singapore (Recruiting)
- Singapore General Hospital — Singapore, Singapore (Recruiting)
- Tan Tock Seng Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Troy Puar Hai Kiat, MRCP, PHD
- Email: troy.puar.h.k@singhealth.com.sg
- Phone: 64267818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.