Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate

NCT03990701 | Completed Early Phase 1

• 1 other identifier: PA_CURE
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma

Keywords

11-C Metomidate PET/CT; Hypertension; Adrenalectomy; Adrenal Vein Sampling; Subtyping

Outcome Measures

Primary Outcomes (1)

• Cure of Primary Aldosteronism Post-Adrenalectomy

  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

  6 months

Secondary Outcomes (2)

• Clinical Diagnosis of Unilateral Primary Aldosteronism

  6 months

• Cost-Effectiveness of Diagnostic Test

  6 months

Other Outcomes (1)

• Diagnostic criteria using 11C-Metomidate PET/CT

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

11C-Metomidate PET/CT Scan COMBINATION_PRODUCT

11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre

Single Arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead
• National University Health System, Singapore: collaborator
• Clinical Imaging Research Centre: collaborator
• Singapore General Hospital: collaborator
• Tan Tock Seng Hospital: collaborator
• Khoo Teck Puat Hospital: collaborator
• Ng Teng Fong General Hospital: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• Puar TH, Khoo CM, Tan CJ, Tong AKT, Tan MCS, Teo AE, Ng KS, Wong KM, Reilhac A, O'Doherty J, Gomez-Sanchez CE, Kek PC, Yee S, Tan AWK, Chuah MB, Lee DHM, Wang KW, Zheng CQ, Shi L, Robins EG, Foo RSY; for the PA CURE investigators. 11C-Metomidate PET-CT versus adrenal vein sampling to subtype primary aldosteronism: a prospective clinical trial. J Hypertens. 2022 Jun 1;40(6):1179-1188. doi: 10.1097/HJH.0000000000003132.

  PMID: 35703880 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: June 19, 2019
• Study Start: May 21, 2018
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)