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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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hyperaldosteronism

Intravenous inject 18F-Pentixather，perform PET/CT imaging at the designated time

Group Type EXPERIMENTAL

[18F]AlF-NOTA-Pentixather

Intervention Type OTHER

inject 185\~370MBq \[18F\]AlF-NOTA-Pentixather

Interventions

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[18F]AlF-NOTA-Pentixather

inject 185\~370MBq \[18F\]AlF-NOTA-Pentixather

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No