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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
Sponsor:
Collaborators:
National University Health System, Singapore
Clinical Imaging Research Centre
Singapore General Hospital
Tan Tock Seng Hospital
Khoo Teck Puat Hospital
Ng Teng Fong General Hospital
Information provided by (Responsible Party):
Changi General Hospital

Brief Summary:

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

Detailed Description:

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.


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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)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Cost-Effectiveness of Diagnostic Test [ Time Frame: 6 months ]
    Cost-Effectiveness of Diagnostic Test to identify unilateral PA


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

  • Inability to provide written informed consent
  • < 21 years or > 70 years
  • Chronic renal failure of Stage 3b or greater severity
  • Severe or terminal medical condition(s)
  • Contraindications to isotope scanning or CT Scan
  • Contraindication to ingestion of corticosteroids

Information from the National Library of Medicine

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


Contacts
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Contact: Troy H Puar, MRCP (UK) 67888833 troy_puar@cgh.com.sg

Locations
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Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Troy H Puar, MRCP UK    +65 68503967    troy_puar@cgh.com.sg   
Principal Investigator: Troy H Puar, MRCP         
Sponsors and Collaborators
Changi General Hospital
National University Health System, Singapore
Clinical Imaging Research Centre
Singapore General Hospital
Tan Tock Seng Hospital
Khoo Teck Puat Hospital
Ng Teng Fong General Hospital

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Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT03990701     History of Changes
Other Study ID Numbers: PA_CURE
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changi General Hospital:
11-C Metomidate PET/CT
Hypertension
Adrenalectomy
Adrenal Vein Sampling
Subtyping
Additional relevant MeSH terms:
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Adenoma
Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Metomidate
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics