11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism
- Conditions
- Primary Hyperaldosteronism
- Interventions
- Procedure: 11C-Metomidate Positron Emission Tomography
- Registration Number
- NCT01567111
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Biochemically proven PA
- Good general health enabling possible adrenalectomy
- BMI less than 35
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects with PA 11C-Metomidate Positron Emission Tomography All study subjects have biochemically confirmed PA and undergo adrenal CT, AVS and MTO-PET to diagnose lateralization of aldosterone production.
- Primary Outcome Measures
Name Time Method Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) 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
Name Time Method Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) Up to 12 weeks Diffences between mean and maximum SUVs in MTO-PET between APA and BAH.
Blood pressure response 1 and 5 years Daily Defined Dosages of hypertension medical therapy in subjects subjected to MRA or adrenalectomy.
Trial Locations
- Locations (3)
Tampere University
🇫🇮Tampere, Finland
University of Turku
🇫🇮Turku, Finland
Helsinki University Central Hospital
🇫🇮Helsinki, Finland