Actively Recruiting
Evaluation of Biodistribution, Dosimetry, Diagnostic and Surgery-guiding Ability of Al18F-NOTA-Pentixafor PET Imaging for Patients With Primary Aldosteronism: A Prospective, Single-center Study
Led by Peking Union Medical College Hospital · Updated on 2025-02-26
150
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary aldosteronism (PA) is a leading cause of secondary hypertension and affects millions worldwide. This study evaluates a new imaging method, Al18F-NOTA-Pentixafor PET/CT, which targets a receptor called CXCR4 found on aldosterone-producing adenomas. Researchers aim to assess how this imaging works, its safety, and how well it helps guide surgery decisions for patients with PA in a prospective, single-center trial. Participants will receive an intravenous injection of the Al18F-NOTA-Pentixafor tracer. After injection, PET and CT scans will be performed within 45-90 minutes to visualize CXCR4-positive lesions. The study will monitor tracer distribution and radiation dose and track diagnostic accuracy and surgical outcomes guided by this imaging over 1 to 1.5 years, including a 6-month follow-up after surgery. Throughout the study, participants will undergo safety assessments from the time of tracer injection up to 24 hours afterward. Researchers will also evaluate diagnostic accuracy based on clinical or pathological diagnoses at 6 months post-imaging and surgical results. Additional measurements include organ uptake of the tracer and radiation dose, monitored up to 6 months after study completion. Participation involves imaging procedures, follow-up visits, and adherence to contraception requirements when applicable.
CONDITIONS
Brief Title
Application of Al18F-NOTA-Pentixafor PET/CT for Primary Aldosteronism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with adrenal masses suspected to be aldosterone-producing adenomas based on routine imaging 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
You will not qualify if you...
- Severe neurological disorders or significant diseases affecting gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, or immune systems
- Diagnosis of claustrophobia
- History of drug abuse or alcohol dependence
- Pregnant or breastfeeding women
- Poor venous access precluding repeated venipuncture
- Use of experimental drugs or devices within one month prior to the study
- Any condition deemed by investigators to pose potential harm or jeopardize participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with imaging 45-90 minutes post-injection
Participants receive an intravenous injection of Al18F-NOTA-Pentixafor followed by PET/CT imaging to assess biodistribution, dosimetry, and diagnostic accuracy for primary aldosteronism.
1 visit (in-person)
Duration - Up to 1 to 1.5 years from enrollment
Participants are monitored for safety and surgical outcomes guided by Al18F-NOTA-Pentixafor PET/CT, including a 6-month follow-up after surgery if applicable.
Follow-up visits over 6 months after imaging and surgery as applicable
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China
Actively Recruiting
Research Team
X
Xinchun Yan, PhD
L
Li Huo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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