RecruitingNot ApplicableNCT06581744

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


Sponsor

Fangfang Sun

Enrollment

20 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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

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Interventions

OTHER[18F]AlF-NOTA-Pentixather

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


Locations(1)

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

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NCT06581744