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CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism | Clinical Trials | Clareo Health

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

NCT06183554•Xiao Chen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

August 31, 2023

Primary Completion Date

August 31, 2025

Completion Date

August 31, 2025

Last Updated

January 3, 2024

Enrollment

ESTIMATED participants

Conditions

Primary Aldosteronism

Interventions

CXCR4

DIAGNOSTIC_TEST

Contacts

Xiao Chen, Ph.D

CONTACT

+8615922970174 xiaochen229@foxmail.com

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)

Prognosis of Primary Aldosteronism: A Prospective Cohort Study

Steroids-Based Screening for Primary Aldosteronism

Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism(SCOPE)

PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism