NCT06100367

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; or unilateral disease (\~60%), cured with laparoscopic surgery (adrenalectomy). Current diagnosis of PA includes a screening test with aldosterone-renin ratio, followed by a confirmatory salt loading test (in most patients) to demonstrate unsuppressed aldosterone levels. Of note, some patients with suppressed aldosterone after confirmatory tests (also termed low-renin hypertension) may also have unilateral adrenal tumors.
  • The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure. An alternative novel imaging, 11C-Metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors which are over-producing aldosterone. It is non-invasive, non-operator-dependent, and potentially may identify more patients with curable unilateral disease. The results from our pilot study in 25 patients with confirmed PA (ClinicalTrials.gov NCT03990701, PA\_CURE) showed that 11C-Metomidate PET-CT exhibited comparable performance to AVS in subtyping PA, and this should be validated in a larger study.
  • In addition, 11C-Metomidate is also able to differentiate adrenocortical lesions in the adrenal gland from other lesions found in adrenal tissue, such as adrenomedullary lesions (e.g. pheochromocytoma).
  • Hence, the investigators hypothesize that 11C-metomidate PET-CT can accurately (1) identify patients with surgically curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism (PA\_CURE 2 / PA\_MTO EH study) and (2) differentiate adrenocortical lesions from other lesions in patients with adrenal tumors (PA\_MTO AT study)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2019

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2019

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

5.4 years

First QC Date

October 13, 2023

Last Update Submit

November 25, 2025

Conditions

Primary Aldosteronism Due to Aldosterone Producing AdenomaPrimary AldosteronismAdrenal Tumors

Keywords

11-C Metomidate PET/CTFunctional imagingSecondary / Endocrine hypertensionAdrenal Vein SamplingSubtyping; localization testingAdrenalectomy

Outcome Measures

Primary Outcomes (2)

  • Biochemical outcome of unilateral primary aldosteronism based on the Primary Aldosteronism Surgical Outcome (PASO) criteria (PA_CURE 2 / PA_MTO EH study).

    The number of patients with complete, partial, and absent biochemical success according to the PASO criteria.

    6 months

  • Diagnostic performance of 11C-Metomidate PET-CT in identifying unilateral adrenocortical tumor (PA_MTO AT study).

    Percentage of patients accurately identified with adrenocortical tumor using 11C-Metomidate PET-CT, when compared to the histopathology of the excised tumor. In patients who have not undergone surgery, this will be determined by clinical diagnosis.

    6 months

Secondary Outcomes (5)

  • Clinical outcome of unilateral primary aldosteronism based on the Primary Aldosteronism Surgical Outcome (PASO) criteria (PA_CURE 2 / PA_MTO EH STUDY).

    6 months

  • Diagnostic performance of 11C-Metomidate PET-CT in identifying unilateral aldosterone-producing adenoma (PA_CURE 2 / PA_MTO EH study).

    6 months

  • Cost-effectiveness of 11C-Metomidate PET-CT versus AVS in diagnosing patients with unilateral primary aldosteronism (PA_CURE 2 / PA_MTO EH STUDY).

    6 months

  • Diagnostic criteria using 11C-metomidate PET/CT (PA_CURE 2 / PA_MTO EH study).

    6 months

  • Number of patients with low-renin hypertension with unilateral adrenal tumors (PA_CURE 2 / PA_MTO EH study).

    6 months

Study Arms (1)

11C-metomidate PET-CT

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 100 - 300 Megabecquerel (MBq) (11C-metomidate) to identify functional unilateral adrenal disease

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

Interventions

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

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

11C-metomidate PET-CT

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Changi General Hospital

Singapore, Singapore

Location

Khoo Teck Puat Hospital

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Ng Teng Fong General Hospital

Singapore, Singapore

Location

Sengkang General Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

HyperaldosteronismAdrenal Gland NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 11C-metomidate synthesis will be done at 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. 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 25, 2023

Study Start

December 30, 2019

Primary Completion

May 25, 2025

Study Completion

December 31, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

SG(7)