Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
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|ClinicalTrials.gov Identifier: NCT03990701|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with laparoscopic surgery (adrenalectomy). Unfortunately, many patients with curable hypertension remain undiagnosed and consequently develop cardiac disease and strokes. The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure, with inconclusive results in 50% of patients. An alternative novel imaging, 11C-metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors, and concurrently confirm their over-activity. It is non-invasive, non-operator-dependent, and can identify more patients with curable hypertension.
Investigators hypothesize that 11C-metomidate PET-CT can accurately identify patients with surgically-curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism.
|Condition or disease||Intervention/treatment||Phase|
|Primary Aldosteronism Primary Aldosteronism Due to Aldosterone Producing Adenoma||Combination Product: 11C-Metomidate PET/CT Scan||Early Phase 1|
25 patients with confirmed PA who are keen for a surgical cure if unilateral PA is confirmed, will undergo conventional tests, CT, AVS, as well as 11C-metomidate PET/CT.
Results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral PA will be offered surgery. Patients will be reviewed 6 months post surgery to assess for cure of PA.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||11C-metomidate will be manufactured in Clinical Imaging Research Centre in compliance with good manufacturing practice using a General Electric Medical Systems PET trace 860 cyclotron. Non-contrast CT images will be acquired over the adrenal. After an intravenous injection of 11C-metomidate, PET images will be acquired within the first 45 min. Attenuation and decay-corrected images will be converted to standardized uptake value (SUV) maps through division by (injected activity per patient weight). The maximum SUV values over regions of interest will be determined for 10-min static images starting 35 min after the injection.|
|Masking:||None (Open Label)|
|Official Title:||Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
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 150 - 300 Megabecquerel (MBq) (11C-metomidate) to identify functional unilateral adrenal disease.
Combination Product: 11C-Metomidate PET/CT Scan
11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre
- Cure of Primary Aldosteronism Post-Adrenalectomy [ Time Frame: 6 months ]Percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using AVS
- Clinical Diagnosis of Unilateral Primary Aldosteronism [ Time Frame: 6 months ]Percentage of patients accurately identified with unilateral PA (determined by clinical diagnosis made by multidisciplinary team) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by clinical diagnosis made by multidisciplinary team) using AVS
- Cost-Effectiveness of Diagnostic Test [ Time Frame: 6 months ]Cost-Effectiveness of Diagnostic Test to identify unilateral PA
- Diagnostic criteria using 11C-Metomidate PET/CT [ Time Frame: 6 months ]To assess the cut-off level of SUVmax which offers the best sensitivity and specificity for lateralisation in 11C-metomidate PET-CT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990701
|Contact: Troy H Puar, MRCP (UK)||firstname.lastname@example.org|
|Changi General Hospital||Recruiting|
|Singapore, Singapore, 529889|
|Contact: Troy H Puar, MRCP UK +65 68503967 email@example.com|
|Principal Investigator: Troy H Puar, MRCP|