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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05188872
Enrollment
100
Registered
2022-01-12
Start date
2020-09-01
Completion date
2027-09-01
Last updated
2026-07-21

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

Conditions

Positron-Emission Tomography

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.

Interventions

DIAGNOSTIC_TEST68Ga-Pentixafor

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

Sponsors

First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Standardized uptake value (SUV)through study completion,an average of 3 yearsStandardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject.

Secondary

MeasureTime frameDescription
SAAE treatment evaluationthrough study completion,an average of 3 years68Ga-Pentixafor PET/CT imaging to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE.

Countries

China

Contacts

CONTACTWeibing Miao, MD
miaoweibing@126.com86-0591-87981618
CONTACTJinxiu Lin, MD
linjinxiu@aliyun.com86-13799777113
STUDY_CHAIRLiangdi Xie, MD

the First Affiliated Hospital, Fujian Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026