GALLIUM (68GA), PENTIXAFOR for Primary aldosteronism | Primary hyperaldosteronism

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old"}
• {"criterion_text":"- Signed written informed consent"}
• {"criterion_text":"- French Social Security affiliation"}
• {"criterion_text":"- For child-bearing aged women, efficient contraception"}
• {"criterion_text":"- Diagnosis of primary aldosteronism: -\tWith or without adrenal nodule on morphological imaging (CT or Magnetic Resonance Imaging) -\tWith unilateral or bilateral aldosterone secretion confirmed by invasive AVS"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- Patient under legal protection (guardianship)"}
• {"criterion_text":"- Contraindication to the PET-CT"}
• {"criterion_text":"- Contraindication to the injection of [68Ga]Ga-PentixaFor"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patient on AME (state medical aid) (unless exemption from affiliation)"}
• {"criterion_text":"- 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 endpoints

• {"endpoint_text":"- Higher SUVmax between both adrenal glands on [68Ga]Ga-PTF-PET imaging","definition_or_measurement_approach":"SUVmax (standardised uptake value maximum) measured in each adrenal gland on [68Ga]Ga-PTF-PET imaging."}
• {"endpoint_text":"- Ratio between SUVmax of both adrenal glands on [68Ga]Ga-PTF-PET imaging calculated as higher SUVmax / lower SUVmax of each adrenal gland","definition_or_measurement_approach":"Ratio calculated as higher SUVmax divided by lower SUVmax between the two adrenal glands on [68Ga]Ga-PTF-PET imaging."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Absolute difference computed as higher SUVmax minus lower SUVmax between the two adrenal glands on [68Ga]Ga-PTF-PET imaging."}
• {"endpoint_text":"- Ratio between the higher SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging","definition_or_measurement_approach":"Ratio of the highest adrenal-gland SUVmax to the mean hepatic SUV measured on [68Ga]Ga-PTF-PET imaging."}

Secondary endpoints

• {"endpoint_text":"- Aldosterone-to-cortisol ratio between the two adrenal veins on AVS (objective 1)","definition_or_measurement_approach":"Aldosterone-to-cortisol ratio measured in each adrenal vein during adrenal venous sampling (AVS)."}
• {"endpoint_text":"- Lateralization index during AVS (objective 1),","definition_or_measurement_approach":"Lateralization index measured during AVS to determine unilateral vs bilateral aldosterone secretion."}
• {"endpoint_text":"- Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging (objective 2),","definition_or_measurement_approach":"Ratio of highest adrenal SUVmax to mean liver SUV on [68Ga]Ga-PTF-PET imaging (as per objective 2)."}
• {"endpoint_text":"- Secretion of aldosterone assessed with blood test after surgical adrenalectomy, dichotomized into persistence of PA at 6 months yes/no (objective 3),","definition_or_measurement_approach":"Post-surgical blood tests to assess aldosterone secretion; outcome dichotomised as persistence of primary aldosteronism at 6 months (yes/no)."}
• {"endpoint_text":"- CXCR4 expression levels by immuno-histochemistry (immunoreactive score or percentage of positive cells) (objective 4),","definition_or_measurement_approach":"Immunohistochemistry measurement of CXCR4 expression reported as immunoreactive score or percentage of positive cells."}
• {"endpoint_text":"- Adenoma sizes on CT and histology (objective 5)","definition_or_measurement_approach":"Measurement of adenoma size on CT imaging and on histology."}
• {"endpoint_text":"- Safety and tolerance of [68Ga]Ga-PentixaFor injections (objective 6)","definition_or_measurement_approach":"Assessment of adverse events and tolerability related to [68Ga]Ga-PentixaFor injections."}
• {"endpoint_text":"- Serious adverse events (any cause).","definition_or_measurement_approach":"Recording and reporting of any serious adverse events regardless of cause."}
• {"endpoint_text":"- CYP11B2 expression levels by immuno- histochemistry (immunoreactive score or percentage of positive cells) (objective 7)","definition_or_measurement_approach":"Immunohistochemistry measurement of CYP11B2 expression reported as immunoreactive score or percentage of positive cells."}
• {"endpoint_text":"- Somatic mutation status of hypersecreting adrenal glands and APA (objective 8).","definition_or_measurement_approach":"Assessment of somatic mutation status of hypersecreting adrenal glands and aldosterone-producing adenomas."}

France

Earliest CTIS Part Ii Submission Date

11-01-2024

Latest Decision Or Authorization Date

18-03-2024

Processing Time Days

67

Number Of Sites

3

Number Of Participants

60

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"AP-HP","duties_or_roles":"Monetary support","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"","full_name":"PentixaPharm","duties_or_roles":"Monetary support","organisation_type":""}