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Study Comparing [68Ga]Ga-PentixaFor PET/CT and AVS for Diagnosing Primary Aldosteronism in Patients with Hypertension

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Primary Aldosteronism, which is a type of hormonal disorder that can lead to high blood pressure. The study is comparing two different methods to diagnose and manage this condition. One method uses a special imaging technique called [68Ga]Ga-PentixaFor PET/CT, which involves a solution for injection that helps to highlight certain areas in the body during a scan. The other method is called AVS, which stands for Adrenal Vein Sampling, a procedure that measures hormone levels directly from the veins of the adrenal glands.

The purpose of the study is to see how well the [68Ga]Ga-PentixaFor PET/CT method works compared to the AVS method in identifying and understanding the condition. Participants in the study will be randomly assigned to either the PET/CT imaging or the AVS procedure. The study will follow participants for a period of time to observe the outcomes of each method, particularly focusing on how they affect blood pressure and overall health.

Throughout the study, researchers will also look at various factors such as the quality of the images produced by the PET/CT scans, the safety of the procedures, and the overall experience of the participants. The study aims to provide valuable information that could improve the diagnosis and treatment of Primary Aldosteronism in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, the diagnosis of primary aldosteronism is confirmed through specific tests, including an elevated aldosterone/renin ratio and an intravenous salt-loading test.
Eligibility is determined based on age (over 18 years) and signed informed consent.
Step 2
Randomization and imaging
Participants are randomly assigned to undergo either [68Ga]Ga-PentixaFor PET/CT imaging or adrenal venous sampling (AVS).
The [68Ga]Ga-PentixaFor is administered intravenously as a solution for injection.
Step 3
Imaging and data collection
The [68Ga]Ga-PentixaFor PET/CT scan is performed to identify and/or determine the location of aldosterone-producing adenomas.
Quantitative data from the imaging is collected, including uptake ratios and comparisons between different types of adrenal conditions.
Step 4
Follow-up and evaluation
Participants are followed up for six months to assess clinical outcomes.
The effectiveness of [68Ga]Ga-PentixaFor PET/CT imaging is compared to AVS in terms of clinical outcomes and subtype diagnosis.
Step 5
Additional assessments
For some participants, a second [68Ga]Ga-PentixaFor PET/CT scan may be conducted within 1-14 days to evaluate reproducibility.
Quality of life is assessed using specific questionnaires, and safety and tolerability are monitored.
Step 6
Final analysis
The study concludes with a comprehensive analysis of the data collected, including cost-effectiveness and image quality assessments.
The trial is estimated to end by September 2028.

Who can join the trial?

4 criteria

The patient must have a diagnosis of primary aldosteronism. This is confirmed by a high aldosterone/renin ratio (ARR) and a test called the intravenous salt-loading test, which follows specific guidelines.
If the patient's condition is uncertain, it will be discussed with all site investigators to agree on the diagnosis before including the patient in the study.
The patient must be over 18 years old at the time of giving consent to participate.
The patient must sign a document called an informed consent, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

Patients who do not have Primary aldosteronism, a condition where the adrenal glands produce too much of a hormone called aldosterone.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, meaning they might need special protection or care.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
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Stichting Radboud University Medical Center
Nijmegen, The Netherlands
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Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

[68Ga]Ga-PentixaFor
This is a special imaging agent used in PET/CT scans. It helps doctors see certain areas in the body more clearly, especially when they are trying to identify or locate specific types of adrenal gland tumors in patients with a condition called primary aldosteronism. This imaging method is being compared to another procedure to see if it provides similar or better results in diagnosing and managing the condition.
AVS (Adrenal Venous Sampling)
This is a diagnostic procedure used to measure hormone levels in the veins of the adrenal glands. It helps doctors determine which adrenal gland is producing too much hormone in patients with primary aldosteronism. This procedure is being compared to the new imaging method to see which one is more effective in diagnosing and treating the condition.

What is already known about the treatment

[68Ga]Ga-PentixaFor – This medication is administered through a PET/CT scan, where it is used as a radiotracer to help visualize certain conditions. It is currently being studied in clinical trials for its effectiveness in diagnosing primary aldosteronism, a condition characterized by excessive production of the hormone aldosterone. The main therapeutic indication is to assist in the identification and localization of aldosterone-producing adenomas. At the molecular level, it targets the CXCR4 receptor, which is often overexpressed in certain tissues. It falls under the pharmacological classification of radiopharmaceuticals used in diagnostic imaging.

Investigated diseases

Primary Aldosteronism – This condition is characterized by the overproduction of the hormone aldosterone by the adrenal glands, which can lead to high blood pressure and low potassium levels. It often results from a benign growth in one or both adrenal glands or from overactivity of both glands. The excess aldosterone causes the kidneys to retain sodium and lose potassium, leading to an imbalance in electrolytes. Over time, this can result in symptoms such as muscle weakness, fatigue, and frequent urination. If left unchecked, the condition can contribute to cardiovascular issues due to persistent high blood pressure. The progression of primary aldosteronism can vary, with some individuals experiencing more severe symptoms than others.