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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05188872
Other study ID # FirstAHFujian12
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2024

Study information

Verified date September 2023
Source First Affiliated Hospital of Fujian Medical University
Contact Weibing Miao, MD
Phone 86-0591-87981618
Email miaoweibing@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary aldosteronism is the most common cause of secondary hypertension. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling(AVS), but the success rate is only about 80%. Using CXCR4 as a probe for 68Ga-Pentixafor PET/CT imaging can guide the classification diagnosis and treatment strategy of primary aldosteronism, which is a favorable supplement to AVS. Superselective adrenal artery embolization(SAAE) and laparoscopy are the main operation treatments for primary aldosteronism. SAAE is an invasive interventional operation. It is a novel way to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE by using the changes in 68Ga-Pentixafor PET/CT imaging.


Description:

Primary aldosteronism: Hypertension is divided into primary hypertension and secondary hypertension. Secondary hypertension refers to hypertension with clear etiology. When the etiology is identified and effectively removed or controlled, hypertension as a secondary symptom can be cured or significantly relieved. The most common secondary hypertension is primary aldosteronism. Primary aldosteronism is due to excessive aldosterone secretion in the adrenal cortex, characterized by clinical syndromes of hyperaldosteronism, low renin activity, hypertension and hypokalemia. Compared with essential hypertension, the risk of cardiovascular and cerebrovascular events and the risk of target organ damage in patients with primary aldosteronism were significantly increased. On the contrary, early detection and treatment mean better blood pressure control, lighter target organ damage and better clinical outcomes. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling (AVS), but the success rate is only about 80 %. Therefore, it is necessary to explore a non-invasive examination method as a beneficial supplement to AVS.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria: - adult population (aged 18 years or order); - patients with suspected or new diagnosed Primary aldosteronism (supporting evidence may include MRI, CT, laboratory tests); - patients who had scheduled 68Ga-BNU-PSMA PET/CT scan; - patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee; - healthy volunteers(aged 18 years or order). Exclusion Criteria: - patients with pregnancy; - the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
68Ga-Pentixafor
Each patient receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT scan within specified time.

Locations

Country Name City State
China Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standardized uptake value (SUV) Standardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject. through study completion,an average of 3 years
Secondary SAAE treatment evaluation 68Ga-Pentixafor PET/CT imaging to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE. through study completion,an average of 3 years
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