Evaluation of [68Ga]Ga-PentixaFor PET Imaging for the Identification of Unilateral Adrenal Secretion of ALdosterON in Patients With Primary Aldosteronism
NCT Number: NCT06478875
Acronym: PENTALON
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Primary Aldosteronism
Interventions: COMBINATION_PRODUCT: [68Ga]Ga-PentixaFor PET imaging
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Pentixapharm AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06
Completion Date: 2027-06
Locations: hôpital Cochin, Paris, 75014, France|Hôpital européen Georges Pompidou - APHP, Paris, 75015, France

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).

Primary Outcome Measures: relevant biomarkers strongly associated with primary lateralized hyperaldosteronism, * 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, 30 days after inclusion
Secondary Outcome Measures: Aldosterone-to-cortisol ratio between the two adrenal veins on AVS, at inclusion|Lateralization index during AVS, at baseline (during AVS day)|Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging, 30 days after inclusion|Proportion of patients with persistence of PA, Patient with a secretion of aldosterone assessed in blood test after surgical adrenalectomy,, 6 months after surgical adrenalectomy|CXCR4 expression levels by immuno-histology highest CXCR4 density, highest CXCR4 density, 6 months after surgical adrenalectomy|Adenoma size on CT, 30 days after inclusion|Adenoma size on histology, 6 months after surgical adrenalectomy|Incidence of Treatment Emergent Adverse Events after [68Ga]Ga-PentixaFor injection (tolerability), * Adverse events deemed "medically significant" defined by Allergic and anaphylactic reaction ≥ grade 3 according to CTCAE during or following the injection of the radiopharmaceutical
* Adverse events of special interest defined by Cutaneous eruption in the three weeks following the injection., 30 days after [68Ga]Ga-PentixaFor injection|Incidence of Treatment Emergent Serious Adverse Events after [68Ga]Ga-PentixaFor injection (Safety), - Serious adverse events (any cause)., 12 months after [68Ga]Ga-PentixaFor injection