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

NCT ID: NCT05188872

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-09-01

Brief 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.

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.

Conditions

Positron-Emission Tomography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-Pentixafor

Each subject receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT imaging within the specificed time

Group Type: EXPERIMENTAL

68Ga-Pentixafor

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

68Ga-Pentixafor

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

PET/CT scan

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weibing Miao, PhD

Director, Department of Nuclear Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liangdi Xie, MD

Role: STUDY_CHAIR

the First Affiliated Hospital, Fujian Medical University

Locations

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weibing Miao, MD

Role: CONTACT

miaoweibing@126.com

86-0591-87981618

Jinxiu Lin, MD

Role: CONTACT

linjinxiu@aliyun.com

86-13799777113

Facility Contacts

Weibing Miao, MD

Role: primary

miaoweibing@126.com

059187981618

Jinxiu Lin, MD

Role: backup

linjinxiu@aliyun.com

86-13799977713

References

Fang Z, Cai H, Zhang Q, Gong J, Zhou W, Xie L, Peng F. Comparative Analysis of Single-Path and Multipath Adrenal Venous Sampling in Primary Aldosteronism. J Interv Cardiol. 2023 Aug 12;2023:8670365. doi: 10.1155/2023/8670365. eCollection 2023.

Reference Type: DERIVED

PMID: 37601238 (View on PubMed)

Other Identifiers

FirstAHFujian12

Identifier Type: -

Identifier Source: org_study_id