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Efficacy of partial or total adrenal aldosteronoma resection based on bilateral adrenal vein blood collection and 68Ga-Pentixafor CXCR4 PET/CT findings: a prospective, randomized, open clinical trial study

Efficacy of partial or total adrenal aldosteronoma resection based on bilateral adrenal vein blood collection and 68Ga-Pentixafor CXCR4 PET/CT findings: a prospective, randomized, open clinical trial study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070830
Enrollment
Unknown
Registered
2023-04-24
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adrenal aldosteronoma

Interventions

Index test:68Ga Pentixa for CXCR4 PET/CT and AVS examination

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients admitted to our hospital with a clinical diagnosis of primary aldosteronism, PA diagnosis followed the guidelines for diagnosis and treatment established by the Chinese Endocrine Society in 2016, mainly through clinical manifestations, screening tests and confirmatory tests, and staging diagnosis was based on 68Ga-Pentixafor CXCR4 PET/CT or AVS results. (AVS was preceded by drug elution as follows: discontinuation of aldosterone receptor antagonists (including spironolactone, eplerenone, etc.), diuretics, and glycopyrrolate preparations for at least 4 weeks; discontinuation of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, dihydropyridine calcium antagonists, beta-receptor antagonists, and central alpha agonists for at least 2 weeks if blood pressure permits; discontinuation of nonsteroidal anti-inflammatory drugs is recommended for at least 2 weeks.) (2) Patients who have had 68Ga-Pentixafor CXCR4 PET/CT and AVS within 30 days prior to unilateral adrenalectomy; (3) Willingness to undergo surgical treatment with sound preoperative and postoperative clinicopathological data; (4) ECOG physical status score 0-2; (5) Patients aged 18 to 75 years old, regardless of gender; (6) Patients without contraindications to PET/CT examination (including diabetic patients with poor glycemic control, patients who cannot lie quietly and flatly for twenty minutes, etc.); (7) Major organ function: no significant abnormalities in liver, kidney, bone marrow, heart and other vital organ functions; (8) Subjects must have the ability to understand and voluntarily sign an informed consent form, which must be signed prior to any trial procedure being conducted; (9) No cortisolism or other malignancy at the time of initial diagnosis.

Exclusion criteria

Exclusion criteria: (1) Patients who have not undergone surgical treatment; (2) Those with abnormal coagulation mechanisms; (3) Patients with other secondary hypertension or combined renal insufficiency [estimated glomerular filtration rate 75 years or <18 years; (5) Those with acute urinary tract infections; (6) Those with severe organ function abnormalities, such as severe abnormalities of heart, lung, liver and kidney function; (7) Those with incomplete data information collection; (8) Patients with diseases or infections related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) (9) Patients with alcohol or narcotic drug abuse, a history of drug use, or a history of psychiatric disorders (e.g., schizophrenia, obsessive-compulsive disorder, depression) with conditions such as antagonistic personality, poor motivation, paranoia, or other emotional or intellectual problems that may affect the informed validity of participation in this study (10) Patients who are unable to cooperate with the relevant tests of this project and do not agree to sign the informed consent form; (11) Patients with the following symptoms within 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack; (12) Patients with persistent arrhythmias = grade 2 (NCI CTCAE Version 4.0 classification); (13) Patients with contraindications to tracers and unable to complete follow-up reviews; (14) Patients with claustrophobia.

Design outcomes

Primary

MeasureTime frame
Blood pressure;Anti-hypertensive drug use;Blood potassium;Aldosterone;Plasma renin concentration;sensitiveness;specificity;positive predictive value;negative predictive value;Correct diagnostic index;

Countries

China

Contacts

Public ContactNing Xu

The First Affiliated Hospital of Fujian Medical University

drxun@fjmu.edu.cn+86 13235907575

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026