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).
The identification of the cause of primary aldosteronism (PA) is critical because, in case of lateralized secretion of aldosterone, a surgical treatment can be offered to patients with the objective of full patient recovery, whereas in case of bilateral secretion, only a long-term medical treatment with mineralocorticoid receptor antagonists should be considered. The presence or absence of adrenal nodule on morphological imaging does not allow us to state on the lateralization or not of aldosterone secretion. Moreover, on one hand, the prevalence of adrenal incidentalomas, mostly non-secreting, can be detected in between 2 to 10% of general population. On the other hand, unilateral secretion of aldosterone exists in 30% of patients with normal adrenal glands on imaging. The AVS with measurements of the concentrations of aldosterone is the closest to a referral exam to confirm the diagnosis of lateralized secretion of aldosterone, but it is a complex and invasive procedure with only limited access to centers with expertise in invasive radiology and an important heterogeneity in interpretation. The development of noninvasive imaging approaches allowing for a more specific identification of lateralized vs. bilateral aldosterone secretion would, hence, have a major impact on the clinical management of these patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
PET imaging of adrenal glands
hôpital Cochin
Paris, France
Hôpital européen Georges Pompidou - APHP
Paris, France
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
Time frame: 30 days after inclusion
Aldosterone-to-cortisol ratio between the two adrenal veins on AVS
Time frame: at inclusion
Lateralization index during AVS
Time frame: 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
Time frame: 30 days after inclusion
Proportion of patients with persistence of PA
Patient with a secretion of aldosterone assessed in blood test after surgical adrenalectomy,
Time frame: 6 months after surgical adrenalectomy
CXCR4 expression levels by immuno-histology highest CXCR4 density
highest CXCR4 density
Time frame: 6 months after surgical adrenalectomy
Adenoma size on CT
Time frame: 30 days after inclusion
Adenoma size on histology
Time frame: 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.
Time frame: 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).
Time frame: 12 months after [68Ga]Ga-PentixaFor injection
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