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NCT Number: NCT06581744

Non Invasive Imaging Methods for Detecting PA：a Clinical 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.

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Key information

Conditions

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116022, China

Location status: Recruiting

Location contact

Lei Xu, PHD

CONTACT

[email protected]

+8641183010706

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

[18F]AlF-NOTA-Pentixather

Other

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

Primary outcomes

  1. Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA

    Time frame: 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).

  2. Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fangfang Sun, MD

CONTACT

[email protected]

18098876916

Wei Song, PHD

CONTACT

[email protected]

18098875773

Sponsors and collaborators

Lead sponsor

Fangfang Sun

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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