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Clinical Trials in France / NCT06478875
Starting soon Phase 2

Evaluation of [68Ga]Ga-PentixaFor PET Imaging for the Identification of Unilateral Adrenal Secretion of ALdosterON in Patients With Primary Aldosteronism

NCT06478875 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Phase 2
Started
2024-06
Last updated
2024-06-27

Condition(s) studied

Primary Aldosteronism

Investigational drug(s) / intervention(s)

[68Ga]Ga-PentixaFor PET imaging

[68Ga]Ga-PentixaFor PET imaging: PET imaging of adrenal glands

Study summary

PentixaFor radiolabeled with 68Gallium (68Ga) is a radiopharmaceutical targeting the CXC chemokine receptor 4 (CXCR4) receptor. The CXCR4 receptor is expressed in zona glomerulosa of the adrenal cortex and in aldosterone producing adenoma (APA). The objective of this study will be to evaluate in 25 patients if \[68Ga\]Ga-PentixaFor positron emission tomography (\[68Ga\]Ga-PTF-PET) imaging allows for the discrimination of patients with lateralized or non-lateralized secretion of aldosterone in adrenal glands classified based on adrenal vein sampling (AVS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years old * Signed written informed consent * French Social Security affiliation * For child-bearing aged women, effective form of contraception\* * Diagnosis of primary aldosteronism: * With or without adrenal nodule on morphological imaging (CT or Magnetic Resonance Imaging) * With unilateral or bilateral aldosterone secretion confirmed by invasive AVS * Such methods include: combined hormonal contraception, progestogen-only hormonal contraception, intrauterine device (IUD) or hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, condom, sexual abstinence. Exclusion Criteria: * Pregnant or breastfeeding women * Patient under legal protection (guardianship) * Contraindication to the PET-CT * Contraindication to the injection of \[68Ga\]Ga-PentixaFor * Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable * Patient on AME (state medical aid) (unless exemption from affiliation) * Completed group: if the expected number of patients has been reached (15 patients) in the corresponding group of patients (with lateralized or non-lateralized PA).

Primary outcome measure(s)

  • relevant biomarkers strongly associated with primary lateralized hyperaldosteronism — 30 days after inclusion
    * Highest max. standardized uptake value (SUVmax) between both adrenal glands on \[68Ga\]Ga-PTF-PET imaging; * Ratio between SUVmax of both adrenal glands on \[68Ga\]Ga-PTF-PET imaging calculated as highest SUVmax / lowest SUVmax of each adrenal gland; * Difference between SUVmax of both adrenal glands on \[68Ga\]Ga-PTF-PET imaging calculated as the difference highest SUVmax - lowest SUVmax of each adrenal gland; * Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on \[68Ga\]Ga-PTF-PET imaging

Trial sites (2)

FacilityCityRegionStatus
hôpital Cochin Paris France
Hôpital européen Georges Pompidou - APHP Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06478875 on ClinicalTrials.gov ↗ ← All trials in France