Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather

Non Invasive Imaging Methods for Detecting Primary Aldosteronism： a Clinical Positron EmissionTomography (PET) Study of 18F-Pentixather

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
• Intervention / Treatment: Other: [18F]AlF-NOTA-Pentixather

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fangfang Sun, MD; Phone Number: 18098876916; Email: sf.f@163.com
• Study Contact Backup: Name: Wei Song, PHD; Phone Number: 18098875773; Email: songwei8124@163.com

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116022
      • Recruiting
      • First Affiliated Hospital of Dalian Medical University
      • Contact: Lei Xu, PHD; Phone Number: +8641183010706; Email: dyyyirb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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: hyperaldosteronism; Intravenous inject 18F-Pentixather，perform PET/CT imaging at the designated time	Other: [18F]AlF-NOTA-Pentixather; inject 185~370MBq [18F]AlF-NOTA-Pentixather

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA	Images were acquired using a Biograph Truepoint 64 PET/CT scanner (Siemens, Erlangen, Germany).The dosimetry analysis was performed using 3d-slicer（version 5.6.1, with slicerOpenDose3D module (https://gitlab.com/opendose/opendose3d). OpenDose: open access resources for nuclear medicine dosimetry (www.opendose.org).	6 month
Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA	Compare the 18F-Pentixather SUVmax with the CXCR4，CYP11B2 immunohistochemical score. Calculate the sensitivity and specificity of 18F-pentixafor PET/CT results for an indication of APA, IAH, or NFA lesions.	3 years

Collaborators and Investigators

• Sponsor: Fangfang Sun

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Primary aldosteronism; Radiation Dosimetry; 18F-Pentixather
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Steroid Metabolism, Inborn Errors; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hyperplasia; Hyperaldosteronism; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome
• Other Study ID Numbers: HYX001

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