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Study on [68Ga]Ga-PentixaFor PET Imaging for Identifying Unilateral Adrenal Aldosterone Secretion in Patients with Primary Aldosteronism

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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 disorder where the adrenal glands produce too much of a hormone called aldosterone. The study will use a special imaging technique called [68Ga]Ga-PentixaFor PET imaging to help identify whether the excess hormone production is coming from one or both adrenal glands. The treatment involves an injection of a solution containing Gallium (68Ga) and Pentixafor, which are substances that help in visualizing the adrenal glands during the imaging process.

The purpose of the study is to evaluate if this imaging method can effectively distinguish between patients with hormone production from one side of the adrenal glands versus both sides. Participants will receive the injection and undergo the PET imaging, which is a type of scan that helps doctors see how the adrenal glands are functioning. The study will monitor the effects of the injection and the imaging results to gather information on how well this method works in identifying the source of hormone production.

Throughout the study, the safety and tolerance of the [68Ga]Ga-PentixaFor injections will be closely observed. The study aims to provide valuable insights into the management of Primary Aldosteronism by potentially offering a new way to pinpoint the source of the problem, which could help in planning further treatment options for patients with this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, consent, and medical history related to primary aldosteronism.

    For women of child-bearing age, confirmation of effective contraception is required.

  2. Step 2

    Preparation for imaging

    Preparation involves scheduling the imaging procedure and providing instructions on any necessary pre-procedure requirements.

  3. Step 3

    Administration of solution

    The solution, [68Ga]Ga-PentixaFor, is administered intravenously. This is a solution for injection used to help visualize adrenal gland activity.

  4. Step 4

    PET imaging

    A PET scan is performed to evaluate the activity of the adrenal glands. This imaging helps identify unilateral adrenal secretion of aldosterone.

    The scan measures the SUVmax (standardized uptake value maximum) in both adrenal glands.

  5. Step 5

    Analysis of imaging results

    The results from the PET scan are analyzed to determine the ratio and difference in SUVmax between the adrenal glands.

    This analysis helps in understanding the lateralization of aldosterone secretion.

  6. Step 6

    Follow-up assessments

    Follow-up assessments may include blood tests and additional imaging to monitor aldosterone levels and adrenal gland function.

    Safety and tolerance of the [68Ga]Ga-PentixaFor injections are evaluated.

  7. Step 7

    Conclusion of participation

    The study concludes with a final assessment to evaluate the outcomes and any changes in the condition.

    Participants are informed of the results and any further recommendations.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Must have **signed written informed consent**, which means you agree to participate after understanding the study.
  • Must be affiliated with **French Social Security**, meaning you have coverage under the French health system.
  • If you are a woman who can have children, you must use **effective contraception** to prevent pregnancy during the study.
  • Must have a **diagnosis of primary aldosteronism**, which is a condition related to hormone production in the adrenal glands. This can be with or without a visible adrenal nodule on imaging tests like CT or MRI. It also includes having either one-sided or both-sided aldosterone secretion confirmed by a special test called **AVS** (Adrenal Vein Sampling).
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Investigated drugs

[68Ga]Ga-PentixaFor is a special imaging agent used in PET scans. It helps doctors see if there is a specific type of hormone secretion happening in the adrenal glands. This is important for patients with a condition called primary aldosteronism, where the body produces too much of a hormone called aldosterone. The imaging agent helps to identify if the hormone is coming from one side of the adrenal glands or both, which can guide treatment decisions.

What is already known about the treatment

[68Ga]Ga-PentixaFor – This medication is administered through a PET imaging procedure, where it is injected into the body to help visualize specific areas. It is currently being studied in clinical trials for its ability to identify unilateral adrenal secretion of aldosterone in patients with primary aldosteronism. The main therapeutic indication is to assist in diagnosing and managing primary aldosteronism by determining if aldosterone secretion is coming from one or both adrenal glands. At the molecular level, it works by binding to specific receptors in the adrenal glands, allowing for clear imaging results. It is classified as a radiopharmaceutical 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 contribute to cardiovascular issues due to persistent high blood pressure. The condition may present with symptoms such as muscle weakness, fatigue, and frequent urination. It is often diagnosed through blood tests and imaging studies to assess hormone levels and adrenal gland function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-505507-22-00Protocol codeAPHP220881Estimated enrolment60 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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