CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism

Study Overview
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Brief Summary
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This study aimed to prospectively evaluate the utility of C-X-C chemokine receptor type 4 (CXCR4) PET/CT in patients with clinical suspected primary aldosteronism (PA), with postoperative pathological or follow-up results as reference standards.

Detailed Description
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Record the course of disease, the laboratory examination (e.g., potassium, aldosterone, aldosterone-to-renin ratio, intravenous salt-loading test or captopril test) and the results of adrenal vein sampling in patients with clinically suspected PA. PET image analysis: Record and evaluate the following indicators: the SUVmax of lesions, the SUVmean of normal liver, the SUVmean of adjacent normal adrenal tissue, the ratio of the lesional SUVmax to the normal liver SUVmean (LLR), and the ratio of the lesional SUVmax to the adjacent adrenal tissue SUVmean (LAR). Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of aldosterone synthase (CYP11B2) and CXCR4.

Official Title
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CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Diagnostic Test: CXCR4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent hypertension with blood pressure > 150/100 mmHg, refractory hypertension (blood pressure >140/90 mmHg with combined use of three types of antihypertensive medications, including diuretics), or with hypokalemia of blood pressure >140/90 mmHg; Refractory hypertension with an aldosterone-to-renin ratio (ARR) ≥ 2.0 (ng/dl)/(mU/L); Positive intravenous salt-loading test or captopril test; Hypertension and adrenal lesions; Patient ≥18 years of age at the time of consent; Provided written informed consent authorisation before participating in the study. Exclusion Criteria: Refusal by the patients to undergo CXCR4 PET/CT, adrenal vein sampling, superselective adrenal and arterial embolizationor adrenalectomy; Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)； Suspicion of adrenocortical carcinoma； Severe comorbidity potentially interfering with treatment or HRQoL； Requirement of medication interfering with the study protocol； Pregnancy or lactation； Estimated glomerular filtration rate <40 mL/min/1.73 m².

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CXCR4|Patients with clinical suspected primary aldosteronism will receive a CXCR4 PET/CT scan.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardised uptake values | Standardised uptake values of suspected adrenal disease in CXCR4 PET imaging | completed within one week after the PET examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemical results | Immunohistochemical evaluation of postoperative adrenal specimens | completed within one week after surgery |