"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"
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- relevant biomarkers strongly associated with primary lateralized hyperaldosteronism
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
relevant biomarkers strongly associated with primary lateralized hyperaldosteronism
时间窗: 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
次要结局
- Lateralization index during AVS(at baseline (during AVS day))
- CXCR4 expression levels by immuno-histology highest CXCR4 density(6 months after surgical adrenalectomy)
- Aldosterone-to-cortisol ratio between the two adrenal veins on AVS(at inclusion)
- Incidence of Treatment Emergent Adverse Events after [68Ga]Ga-PentixaFor injection (tolerability)(30 days after [68Ga]Ga-PentixaFor injection)
- 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)
- Incidence of Treatment Emergent Serious Adverse Events after [68Ga]Ga-PentixaFor injection (Safety)(12 months after [68Ga]Ga-PentixaFor injection)
- Adenoma size on CT(30 days after inclusion)
- Adenoma size on histology(6 months after surgical adrenalectomy)