Status:
ACTIVE_NOT_RECRUITING
11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours
Lead Sponsor:
Changi General Hospital
Collaborating Sponsors:
National University Health System, Singapore
Clinical Imaging Research Centre
Conditions:
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
* The investigators aim to recruit 100 patients with confirmed, or likely, primary aldosteronism to undergo conventional tests, CT, AVS, and 11C-metomidate PET-CT. * Results will be reviewed and discu...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
December 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06100367
Start Date
December 30 2019
End Date
December 31 2025
Last Update
December 2 2025
Active Locations (7)
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1
Changi General Hospital
Singapore, Singapore
2
Khoo Teck Puat Hospital
Singapore, Singapore
3
National University Hospital
Singapore, Singapore
4
Ng Teng Fong General Hospital
Singapore, Singapore