Clinical trial NCT01567111: 11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hyperaldosteronism
Keywords: Primary aldosteronism
Aldosterone producing adenoma
Bilateral adrenal hyperplasia
Metomidate-Positron emission tomography
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Tampere University
First posted: 2012-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
timeFrame: Up to 12 weeks
measure: Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
timeFrame: Up to 12 weeks
measure: Blood pressure response
timeFrame: 1 and 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: Helsinki University Central Hospital
name: Niina Matikainen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: