Clinical Trial: 11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 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.


Detailed Summary:
Sponsor: Helsinki University Central Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Helsinki University Central Hospital

Dates:
Date Received: March 26, 2012
Date Started: February 2012
Date Completion: December 2022
Last Updated: February 28, 2017
Last Verified: February 2017