Clinical trial NCT06581744: Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather
Official title: Non Invasive Imaging Methods for Detecting Primary Aldosteronism： a Clinical Positron EmissionTomography (PET) Study of 18F-Pentixather
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Keywords: Primary aldosteronism
Radiation Dosimetry
18F-Pentixather
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. \[18F\]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent(\[18F\]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. \[18F\]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram \[ID/g\] at 1 hour post injection\[p.i.\]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of \[18F\]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the \[18F\]AlF-NOTA-Pentixather as a probe for APA.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with primary aldosteronism and willing to undergo surgery
2. Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
3. Postoperative recurrence in patients with primary aldosteronism

Exclusion Criteria:

1. Pregnant and lactating women.
2. Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
3. There are other situations where patients are not suitable for this examination

Primary outcomes:
measure: Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA
timeFrame: 6 month
measure: Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
References:
citation: Zheng Y, Long T, Peng N, Zhen M, Ye Q, Zhang Z, He Y, Chen Z, Gan Y, Luo M, Li C, Liu Z, Guo M, Wang M, Luo X, Hu S, Liu L, Jiang T. The Value of Targeting CXCR4 With 68Ga-Pentixafor PET/CT for Subtyping Primary Aldosteronism. J Clin Endocrinol Metab. 2023 Dec 21;109(1):171-182. doi: 10.1210/clinem/dgad421.
citation: Gao Y, Ding J, Cui Y, Li T, Sun H, Zhao D, Zhang Y, Huo L, Tong A. Functional nodules in primary aldosteronism: identification of CXCR4 expression with 68Ga-pentixafor PET/CT. Eur Radiol. 2023 Feb;33(2):996-1003. doi: 10.1007/s00330-022-09058-x. Epub 2022 Sep 7.