Primary Aldosteronism
Conditions
Keywords
[68Ga]Ga-PentixaFor positron emission tomography, adrenal vein sampling, unilateral adrenal secretion
Brief 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).
Detailed description
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.
Interventions
COMBINATION_PRODUCT[68Ga]Ga-PentixaFor PET imaging
PET imaging of adrenal glands
Sponsors
Pentixapharm AG
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months after surgical adrenalectomy | Patient with a secretion of aldosterone assessed in blood test after surgical adrenalectomy, |
| CXCR4 expression levels by immuno-histology highest CXCR4 density | 6 months after surgical adrenalectomy | highest CXCR4 density |
| Aldosterone-to-cortisol ratio between the two adrenal veins on AVS | at inclusion | — |
| Adenoma size on histology | 6 months after surgical adrenalectomy | — |
| Incidence of Treatment Emergent Adverse Events after [68Ga]Ga-PentixaFor injection (tolerability) | 30 days after [68Ga]Ga-PentixaFor injection | * 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. |
| Incidence of Treatment Emergent Serious Adverse Events after [68Ga]Ga-PentixaFor injection (Safety) | 12 months after [68Ga]Ga-PentixaFor injection | \- Serious adverse events (any cause). |
| Adenoma size on CT | 30 days after inclusion | — |
Countries
France
Contacts
Primary ContactTouria AL AAMRI
Backup ContactLiliane HAMMANI-BERKANI
Outcome results
None listed