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

Not Applicable

Recruiting

• Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

• Registration Number: NCT06581744
• Lead Sponsor: Fangfang Sun

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-29
• Last Update Submitted: 2024-08-29
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2024-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA	6 month	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).
Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA	3 years	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.

Trial Locations

Locations (1)

First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China