Status:

RECRUITING

Application of Al18F-NOTA-Pentixafor PET/CT for Primary Aldosteronism

Lead Sponsor:

Peking Union Medical College Hospital

Conditions:

Primary Aldosteronism

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

PHASE2

Brief Summary

This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-Pentixafor PET imaging in patients with primary aldosteronism. And evalu...

Detailed Description

Hypertension has a high prevalence, being a leading cause of premature death in 1.4 billion adults worldwide. Primary aldosteronism (PA) is the most common cause of secondary hypertension. Guidelines ...

Eligibility Criteria

Inclusion Criteria:

  1. Patients with adrenal masses suspected to be aldosterone-producing adenomas based on routine imaging (e.g., CT scans), or clinically diagnosed primary aldosteronism patients requiring subtyping
  2. Signed written informed consent, with willingness and ability to comply with study procedures.
  3. Female participants must be surgically sterilized or postmenopausal for over a year; if not, reliable contraception is required.
  4. Male participants must use reliable contraception during the study and refrain from sperm donation.

Exclusion Criteria:

  1. Severe neurological disorders, or any significant diseases affecting the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, or immune systems, or other serious illnesses.
  2. Diagnosis of claustrophobia.
  3. History of drug abuse or alcohol dependence.
  4. Pregnant or breastfeeding women.
  5. Poor venous access that would preclude repeated venipuncture.
  6. Use of experimental drugs or devices within one month prior to the study, where the safety or efficacy has not been established.
  7. Any condition that the study investigators deem could pose potential harm or jeopardize participant safety.

Key Trial Info

Start Date :

December 30 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 30 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06773663

Start Date

December 30 2023

End Date

October 30 2026

Last Update

February 26 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, China