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
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||Phase|
|Primary Hyperaldosteronism||Procedure: 11C-Metomidate Positron Emission Tomography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2022|
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)
- 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.
- 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.
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|
|University of Turku|
|Principal Investigator:||Niina Matikainen, M.D., Ph.D.||Helsinki University Central Hospital|