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PENTALON - Pilot study for the evaluation of [68Ga]Ga-PentixaFor PET imaging for the identification of unilateral adrenal secretion of ALdosterON in patients with primary aldosteronism.

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505507-22-00
Acronym
APHP220881
Enrollment
60
Registered
2024-03-18
Start date
2024-09-12
Completion date
Unknown
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary aldosteronism

Brief summary

Higher 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 higher SUVmax / lower SUVmax of each adrenal gland, Difference between SUVmax of both adrenal glands on [68Ga]Ga-PTF-PET imaging calculated as the difference higher SUVmax - lower SUVmax of each adrenal gland, Ratio between the higher SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging

Detailed description

Aldosterone-to-cortisol ratio between the two adrenal veins on AVS (objective 1), Lateralization index during AVS (objective 1),, Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging (objective 2),, Secretion of aldosterone assessed with blood test after surgical adrenalectomy, dichotomized into persistence of PA at 6 months yes/no (objective 3),, CXCR4 expression levels by immuno-histochemistry (immunoreactive score or percentage of positive cells) (objective 4),, Adenoma sizes on CT and histology (objective 5), Safety and tolerance of [68Ga]Ga-PentixaFor injections (objective 6), Serious adverse events (any cause)., CYP11B2 expression levels by immuno- histochemistry (immunoreactive score or percentage of positive cells) (objective 7), Somatic mutation status of hypersecreting adrenal glands and APA (objective 8).

Interventions

Sponsors

Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Higher 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 higher SUVmax / lower SUVmax of each adrenal gland, Difference between SUVmax of both adrenal glands on [68Ga]Ga-PTF-PET imaging calculated as the difference higher SUVmax - lower SUVmax of each adrenal gland, Ratio between the higher SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging

Secondary

MeasureTime frame
Aldosterone-to-cortisol ratio between the two adrenal veins on AVS (objective 1), Lateralization index during AVS (objective 1),, Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging (objective 2),, Secretion of aldosterone assessed with blood test after surgical adrenalectomy, dichotomized into persistence of PA at 6 months yes/no (objective 3),, CXCR4 expression levels by immuno-histochemistry (immunoreactive score or percentage of positive cells) (objective 4),, Adenoma sizes on CT and histology (objective 5), Safety and tolerance of [68Ga]Ga-PentixaFor injections (objective 6), Serious adverse events (any cause)., CYP11B2 expression levels by immuno- histochemistry (immunoreactive score or percentage of positive cells) (objective 7), Somatic mutation status of hypersecreting adrenal glands and APA (objective 8).

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026