Overview

This trial is active, not recruiting.

Condition primary hyperaldosteronism
Treatment 11c-metomidate positron emission tomography
Sponsor Helsinki University Central Hospital
Collaborator Turku University Hospital
Start date February 2012
End date August 2015
Trial size 40 participants
Trial identifier NCT01567111, T79/2011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
All study subjects have biochemically confirmed PA and undergo adrenal CT, AVS and MTO-PET to diagnose lateralization of aldosterone production.
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)

Primary Outcomes

Measure
Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
time frame: Up to 12 weeks

Secondary Outcomes

Measure
Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
time frame: Up to 12 weeks
Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
time frame: Up to 12 weeks
Blood pressure response
time frame: 1 and 5 years

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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

Additional Information

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
Principal investigator Niina Matikainen, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.