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

Primary Hyperaldosteronism Clinical Trial

— MIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567111
• Other study ID #: T79/2011
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2019
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Hyperaldosteronism

Intervention

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)

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Tampere University	Tampere
Finland	University of Turku	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Tampere University, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)	Mean and maximun SUV-values detect lateralization / no lateralization in aldosterone production in MTO-PET as compared to AVS.	Up to 12 weeks
Secondary	Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)	Mean and maximun SUV-values detect lateralization / no lateralization in aldosterone production in MTO-PET as compared to adrenal CT.	Up to 12 weeks
Secondary	Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)	Diffences between mean and maximum SUVs in MTO-PET between APA and BAH.	Up to 12 weeks
Secondary	Blood pressure response	Daily Defined Dosages of hypertension medical therapy in subjects subjected to MRA or adrenalectomy.	1 and 5 years