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11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism (MIA)

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ClinicalTrials.gov Identifier: NCT01567111
Recruitment Status : Active, not recruiting
First Posted : March 30, 2012
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of secondary hypertension. The diagnosis and targeted treatment of PA is essential because of high vascular morbidity associated with PA as compared to essential hypertension with comparable blood pressure levels. PA is usually caused by either a unilateral aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction between APA and BAH is critical since the former may be cured by adrenalectomy, and the latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA). Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s) producing the most of aldosterone excess. The distinction between unilateral and bilateral PA can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008 guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning which does not distinguish between aldosterone-producing and common non-functioning adrenal nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive, dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).

Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar in histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial remission rates (blood pressure response expressed in Daily Defined Dosages, medical therapy, use of potassium supplements) after allocating subjects to MRA-therapy or adrenalectomy at 1 and 5 years.

Condition or disease Intervention/treatment
Primary Hyperaldosteronism Procedure: 11C-Metomidate Positron Emission Tomography

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Imaging With 11C-Metomidate Positron Emission Tomography Versus Adrenal Vein Sampling in Differential Diagnosis of Unilateral and Bilateral Aldosterone Secretion in Primary Aldosteronism
Study Start Date : February 2012
Primary Completion Date : August 2015
Estimated Study Completion Date : December 2022

Arms and Interventions

Arm Intervention/treatment
Experimental: Subjects with PA
All study subjects have biochemically confirmed PA and undergo adrenal CT, AVS and MTO-PET to diagnose lateralization of aldosterone production.
Procedure: 11C-Metomidate Positron Emission Tomography
Dose of intravenous 11C-Metomidate injection is 440MBq and emission scanning of upper abdomen. PET/CT imaging will be done using the Discovery PET/CT VCT or 690 scanner (General Electric Medical Systems, Milwaukee, WI, USA)

Outcome Measures

Primary Outcome Measures :
  1. Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) [ Time Frame: Up to 12 weeks ]
    Mean and maximun SUV-values detect lateralization / no lateralization in aldosterone production in MTO-PET as compared to AVS.

Secondary Outcome Measures :
  1. Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) [ Time Frame: Up to 12 weeks ]
    Mean and maximun SUV-values detect lateralization / no lateralization in aldosterone production in MTO-PET as compared to adrenal CT.

  2. Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) [ Time Frame: Up to 12 weeks ]
    Diffences between mean and maximum SUVs in MTO-PET between APA and BAH.

  3. Blood pressure response [ Time Frame: 1 and 5 years ]
    Daily Defined Dosages of hypertension medical therapy in subjects subjected to MRA or adrenalectomy.

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biochemically proven PA
  • Good general health enabling possible adrenalectomy
  • BMI less than 35

Exclusion Criteria:

  • Any contraindication for AVS, MTO-PET or CT
  • Subjects not willing to consider adrenal surgery
  • Pregnancy
  • Familial PA
  • Suspicion of other tumor than adenoma or hyperplasia in adrenal CT scan
Contacts and Locations

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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): NCT01567111

Helsinki University Central Hospital
Helsinki, Finland
Tampere University
Tampere, Finland
University of Turku
Turku, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Turku University Hospital
University of Tampere
Principal Investigator: Niina Matikainen, M.D., Ph.D. Helsinki University Central Hospital
More Information

Responsible Party: Niina Matikainen, M.D., Ph.D., Specialist in endocrinology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01567111     History of Changes
Other Study ID Numbers: T79/2011
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Niina Matikainen, Helsinki University Central Hospital:
Primary aldosteronism
Aldosterone producing adenoma
Bilateral adrenal hyperplasia
Metomidate-Positron emission tomography

Additional relevant MeSH terms:
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Intravenous
Anesthetics, General