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

NCT03990701 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-06-01

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

11C-Metomidate PET/CT Scan

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

Sponsors & Collaborators

  • National University Health System, Singapore

    collaborator OTHER

  • Clinical Imaging Research Centre

    collaborator UNKNOWN

  • Singapore General Hospital

    collaborator OTHER

  • Tan Tock Seng Hospital

    collaborator OTHER

  • Khoo Teck Puat Hospital

    collaborator OTHER

  • Ng Teng Fong General Hospital

    collaborator OTHER

  • Changi General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990701 on ClinicalTrials.gov