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:
- 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
- Signed written informed consent, with willingness and ability to comply with study procedures.
- Female participants must be surgically sterilized or postmenopausal for over a year; if not, reliable contraception is required.
- Male participants must use reliable contraception during the study and refrain from sperm donation.
Exclusion Criteria:
- Severe neurological disorders, or any significant diseases affecting the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, or immune systems, or other serious illnesses.
- Diagnosis of claustrophobia.
- History of drug abuse or alcohol dependence.
- Pregnant or breastfeeding women.
- Poor venous access that would preclude repeated venipuncture.
- Use of experimental drugs or devices within one month prior to the study, where the safety or efficacy has not been established.
- 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)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China