Using Al18F-NOTA-Pentixafor PET/CT to improve diagnosis of primary aldosteronism

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

This study is testing a new imaging method to see if it can help doctors better diagnose primary aldosteronism in patients with high blood pressure.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06773663 on ClinicalTrials.gov

What this trial studies

This interventional study evaluates the effectiveness of Al18F-NOTA-Pentixafor PET imaging in diagnosing primary aldosteronism, a common cause of secondary hypertension. It aims to assess the biodistribution, dosimetry, safety, and diagnostic performance of this imaging technique in patients with suspected aldosterone-producing adenomas. By comparing it to the current gold standard, adrenal vein sampling, the study seeks to provide a less invasive and more accessible diagnostic option for patients. The ultimate goal is to enhance surgical strategy guidance and improve patient outcomes through early diagnosis and treatment.

Who should consider this trial

Good fit: Ideal candidates include patients with adrenal masses suspected to be aldosterone-producing adenomas or those clinically diagnosed with primary aldosteronism requiring subtyping.

Not a fit: Patients with severe comorbid conditions, claustrophobia, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective diagnostic tool for patients with primary aldosteronism, leading to better treatment outcomes.

How similar studies have performed: While the use of PET imaging in this context is relatively novel, similar imaging techniques have shown promise in other diagnostic applications, suggesting potential for success.

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.

Where this trial is running

Beijing

• Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xinchun Yan, PhD

Conditions Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma