11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism
Information source: Helsinki University Central Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Hyperaldosteronism
Intervention: 11C-Metomidate Positron Emission Tomography (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Helsinki University Central Hospital Official(s) and/or principal investigator(s): Niina Matikainen, M.D., Ph.D., Principal Investigator, Affiliation: Helsinki University Central Hospital
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.
Clinical Details
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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)
Secondary outcome: Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) Blood pressure response
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Helsinki University Central Hospital, Helsinki, Finland
Tampere University, Tampere, Finland
University of Turku, Turku, Finland
Additional Information
Starting date: February 2012
Last updated: August 17, 2015
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