RecruitingPhase 1/2

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

China150 participantsStarted 2023-12-30

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

Safety of Al18F-NOTA-Pentixafor

Timeframe: From radiotracer injection to 24 hours post-injection.

Diagnostic accuracy of Al18F-NOTA-Pentixafor PET/CT for PA

Timeframe: Through study completion, 1-1.5 years (from enrollment to to the final clinical or pathological diagnosis at 6-month follow-up after Al18F-NOTA-Pentixafor PET/CT )

Surgical outcomes guided by Al18F-NOTA-Pentixafor PET/CT

Timeframe: Through study completion, 1-1.5 years (from enrollment to 6-month follow-up after surgery guided by Al18F-NOTA-Pentixafor PET/CT)

Trial details

NCT IDNCT06773663

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

Contact for this trial

Xinchun Yan, PhD

+86 18513489856 xcyanpumch@163.com

View on ClinicalTrials.gov More Primary Aldosteronism trials