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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 evaluates the potential of Al18F-NOTA-Pentixafor PET imaging in surgical strategy guidance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
RECRUITING
Beijing
Contact Information
Primary
Xinchun Yan, PhD
xcyanpumch@163.com
+86 18513489856
Backup
Li Huo, MD
huoli@pumch.cn
Time Frame
Start Date: 2023-12-30
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 150
Treatments
Experimental: Al18F-NOTA-Pentixafor PET/CT
Evaluation of dosimetry, safety, diagnostic accuracy, and surgical guidance ability of Al18F-NOTA-Pentixafor PET/CT in patients with primary aldosteronism
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov