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

NCT01567111 | Completed

• 1 other identifier: T79/2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary Hyperaldosteronism

Keywords

Primary aldosteronism; Aldosterone producing adenoma; Bilateral adrenal hyperplasia; Metomidate-Positron emission tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)

  Up to 12 weeks

• Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)

  Up to 12 weeks

• Blood pressure response

  1 and 5 years

Study Arms (1)

Subjects with PA

EXPERIMENTAL

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

Interventions

11C-Metomidate Positron Emission Tomography PROCEDURE

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)

Subjects with PA

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biochemically proven PA
• Good general health enabling possible adrenalectomy
• BMI less than 35

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Turku University Hospital: collaborator
• Tampere University: collaborator

Study Sites (3)

Helsinki University Central Hospital

Helsinki, Finland

Location

Tampere University

Tampere, Finland

Location

University of Turku

Turku, Finland

Location

MeSH Terms

Conditions

Hyperaldosteronism; Adrenocortical Adenoma

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases

Study Officials

• Niina Matikainen, M.D., Ph.D.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Specialist in endocrinology

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 30, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: March 1, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

FI (3)