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

Last updated: August 29, 2024
Sponsor: Fangfang Sun
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congenital Adrenal Hyperplasia

Treatment

[18F]AlF-NOTA-Pentixather

Clinical Study ID

NCT06581744
HYX001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients diagnosed with primary aldosteronism and willing to undergo surgery

  2. Clinically highly suspected of primary aldosteronism, but the diagnostic test cannotclearly identify the patients

  3. Postoperative recurrence in patients with primary aldosteronism

Exclusion

Exclusion Criteria:

  1. Pregnant and lactating women.

  2. Patients with poor autonomous behavior ability, severe claustrophobia, andcritically ill patients requiring life support who are unable to cooperate incompleting the examination.

  3. There are other situations where patients are not suitable for this examination

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: [18F]AlF-NOTA-Pentixather
Phase:
Study Start date:
June 12, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116022
    China

    Active - Recruiting

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