Primary HyperaldosteronismMIANCT01567111
11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism
A study testing 11C-Metomidate Positron Emission Tomography in people with Primary Hyperaldosteronism, run by Helsinki University Central Hospital at 3 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Primary Hyperaldosteronism
- What is being tested?
- 11C-Metomidate Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFinland
- Study dates
- Feb 2012to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biochemically proven PA
- Good general health enabling possible adrenalectomy
- BMI less than 35
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Central Hospital
Helsinki
Tampere University
Tampere
University of Turku
Turku
About this study
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
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
- Being tested
- 11C-Metomidate Positron Emission Tomography
- Keywords
- Primary aldosteronism, Aldosterone producing adenoma, Bilateral adrenal hyperplasia, Metomidate-Positron emission tomography
- Medical subject headings
- Hyperaldosteronism, Adrenocortical Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-Metomidate Positron Emission TomographyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 11C-Metomidate Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Secondary outcomes (3)
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
Blood pressure response
Daily Defined Dosages of hypertension medical therapy in subjects subjected to MRA or adrenalectomy.
Measured: 1 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Tampere University
- Responsible party
- Principal investigator, Niina Matikainen, Helsinki University Central Hospital
- Investigators
- Niina Matikainen, M.D., Ph.D., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567111
- Sponsor's protocol ID
- T79/2011
- Acronym
- MIA
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2012
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01567111
- Acronym / sponsor ID
- MIA / T79/2011
- Conditions
- Primary Hyperaldosteronism
- Keywords
- Primary aldosteronism, Aldosterone producing adenoma, Bilateral adrenal hyperplasia, Metomidate-Positron emission tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Tampere University
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with PA | Experimental | Procedure: 11C-Metomidate Positron Emission TomographyAll study subjects have biochemically confirmed PA and undergo adrenal CT, AVS and MTO-PET to diagnose lateralization of aldosterone production. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biochemically proven PA
- Good general health enabling possible adrenalectomy
- BMI less than 35
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-Metomidate Positron Emission TomographyDose 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) | Procedure or surgery | Subjects with PA |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niina Matikainen, M.D., Ph.D. principal investigator
Helsinki University Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-Metomidate Positron Emission Tomography in people with Primary Hyperaldosteronism, run by Helsinki University Central Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.