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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Helsinki University Central Hospital
Sponsor:
Collaborators:
Turku University Hospital
University of Tampere
Information provided by (Responsible Party):
Niina Matikainen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01567111
First received: March 26, 2012
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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 Intervention
Primary Hyperaldosteronism
Procedure: 11C-Metomidate Positron Emission Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

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


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

  • Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Diffences between mean and maximum SUVs in MTO-PET between APA and BAH.

  • Blood pressure response [ Time Frame: 1 and 5 years ] [ Designated as safety issue: No ]
    Daily Defined Dosages of hypertension medical therapy in subjects subjected to MRA or adrenalectomy.


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567111

Contacts
Contact: Niina Matikainen, M.D., Ph.D. niina.matikainen@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Principal Investigator: Matti Välimäki, Professor         
Tampere University Recruiting
Tampere, Finland
Principal Investigator: Pasi Nevalainen, M.D., Ph.D.         
University of Turku Recruiting
Turku, Finland
Principal Investigator: Pirjo Nuutila, Professor         
Sub-Investigator: Minna Soinio, M.D., Ph.D.         
Sponsors and Collaborators
Helsinki University Central Hospital
Turku University Hospital
University of Tampere
Investigators
Principal Investigator: Niina Matikainen, M.D., Ph.D. Helsinki University Central Hospital
  More Information

No publications provided

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
Study First Received: March 26, 2012
Last Updated: March 28, 2012
Health Authority: Finland: Ministry of Social Affairs and Health

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

Additional relevant MeSH terms:
Adrenal Gland Diseases
Hyperaldosteronism
Adrenocortical Hyperfunction
Endocrine System Diseases
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014