Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE

68Ga-Pentixafor PET/CT in the Diagnosis of Primary Aldosteronism and Pre-postoperative of Superselective Adrenal Artery Embolization

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.

Study Overview

• Status: Recruiting
• Conditions: Positron-Emission Tomography
• Intervention / Treatment: Diagnostic test: 68Ga-Pentixafor

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinxiu Lin, MD; Phone Number: 86-13799777113; Email: linjinxiu@aliyun.com
• Study Contact Backup: Name: Weibing Miao, MD; Phone Number: 86-0591-87981618; Email: miaoweibing@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
      • Contact: Jinxiu Lin, MD; Phone Number: 86-13799977713; Email: linjinxiu@aliyun.com
      • Contact: Weibing Miao, MD; Phone Number: 059187981618; Email: miaoweibing@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-Pentixafor; Each subject receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT imaging within the specificed time	Diagnostic test: 68Ga-Pentixafor; Each patient receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT scan within specified time.; Other Names: PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University
• Investigators: Study Chair: Liangdi Xie, MD, the First Affiliated Hospital, Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: FirstAHFujian12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No