CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the effectiveness of CXCR4 targeted PET imaging in preoperative localization diagnosis of primary aldosteronism (PA). Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET, and then underwent adrenal venous sampling (AVS). Then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. Researchers will compare the sensitivity and specificity between 68Ga-PentixaFor PET imaging and AVS in preoperative localization diagnosis of PA.

Official Title
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A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism

Conditions
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Aldosterone-Producing Adenoma

Intervention / Treatment
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* Diagnostic Test: CXCR4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PA, confirmed by an elevated aldosterone/renin ratio (ARR) and an intravenous salt loading test. The patient has provided written informed consent authorisation before participating in the study. The patient is 18 to 70 years of age at the time of consent. Exclusion Criteria: Refusal by the patients to undergo 68Ga-PentixaFor PET/CT, AVS, CT, or 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 health-related quality of life. Patients need to take drugs that interfere with clinical research. Any medical condition present that in the opinion of the investigator will affect patients clinical status. Pregnancy or lactation. Estimated glomerular filtration rate <40mL/min/1.73m2. Interfering treatment in between 68Ga-PentixaFor PET/CT and AVS.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CXCR4<br>scanned by 68Ga-PentixaFor PET imaging | Diagnostic Test: CXCR4<br>* Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renin | measure the level of renin in blood | immediately after admission | 
| aldosterone | measure the level of aldosterone in blood | immediately after admission | 
| SUVmax | measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal | immediately after 68Ga-PentixaFor PET imaging | 
| sensitivity | the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA | immediately after pathological examination | 
| specificity | the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA | immediately after pathological examination | 
| positive predictive value,PPV | the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA | immediately after pathological examination | 
| negative predictive value, NPV | the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA | immediately after pathological examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hypokalemia, Adrenal adenoma