CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

Zhongnan Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Aldosterone-Producing Adenoma

Interventions

CXCR4DIAGNOSTIC_TEST

Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

renin

measure the level of renin in blood

Time frame: immediately after admission

aldosterone

measure the level of aldosterone in blood

Time frame: immediately after admission

SUVmax

measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal

Time frame: immediately after 68Ga-PentixaFor PET imaging

sensitivity

the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

Time frame: immediately after pathological examination

specificity

the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

Time frame: immediately after pathological examination

positive predictive value,PPV

the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

Time frame: immediately after pathological examination

negative predictive value, NPV

the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

Time frame: immediately after pathological examination

Central Contacts

Zhe Meng

CONTACT

+86 15387041020 mengzhe@whu.edu.cn

Data from ClinicalTrials.gov

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