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

Recruiting

• Conditions: Primary Aldosteronism

• Registration Number: NCT06183554
• Lead Sponsor: Xiao Chen

Brief Summary

This study aimed to prospectively evaluate the utility of C-X-C chemokine receptor type 4 (CXCR4) positron emission tomography (PET) imaging in patients with clinical suspected primary aldosteronism (PA), with postoperative pathological or follow-up results as reference standards.

Detailed Description

1. 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.

2. PET image analysis: Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the mean standardized uptake value (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).

3. 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.

Study Timeline

• Study Start: 2023-08-31
• Status Verified: 2023-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-27
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-03
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 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;
2. Refractory hypertension with an aldosterone-to-renin ratio (ARR) ≥ 2.0 (ng/dl)/(mU/L);
3. Positive intravenous salt-loading test or captopril test;
4. Hypertension and adrenal lesions;
5. Patient ≥18 years of age at the time of consent;
6. Provided written informed consent authorisation before participating in the study.

Exclusion Criteria

1. Refusal by the patients to undergo CXCR4 PET imaging, adrenal vein sampling, superselective adrenal arterial embolization or adrenalectomy;
2. Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)；
3. Suspicion of adrenocortical carcinoma；
4. Severe comorbidity potentially interfering with treatment or HRQoL；
5. Requirement of medication interfering with the study protocol；
6. Pregnancy or lactation；
7. Estimated glomerular filtration rate <40 mL/min/1.73 m².

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Standardised uptake values	completed within one week after the PET examination	Standardised uptake values of suspected adrenal disease in CXCR4 PET imaging

Secondary Outcome Measures

Name	Time	Method
Immunohistochemical results	completed within one week after surgery	Immunohistochemical evaluation of postoperative adrenal specimens

Trial Locations

Locations (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China