Primary AldosteronismPrimary Aldosteronism Due to Aldosterone Producing Adenoma
Investigational drug(s) / intervention(s)
Al18F-NOTA-Pentixafor PET/CT
Al18F-NOTA-Pentixafor PET/CT: Participants will receive an intravenous injection of Al18F-NOTA-Pentixafor, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline.
The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling.
CT and PET imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability.
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety of Al18F-NOTA-Pentixafor — From radiotracer injection to 24 hours post-injection. Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Diagnostic accuracy of Al18F-NOTA-Pentixafor PET/CT for PA — 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 ) SUVmax and SUVmean of adrenal lesions, normal adrenal glands, and liver will be measured. The lesion-to-liver ratio (LLR) and lesion-to-normal adrenal ratio (LAR) will be calculated. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or adrenal vein sampling (AVS) findings will serve as the reference standard to determine the sensitivity and specificity .
Surgical outcomes guided by Al18F-NOTA-Pentixafor PET/CT — Through study completion, 1-1.5 years (from enrollment to 6-month follow-up after surgery guided by Al18F-NOTA-Pentixafor PET/CT) Primary Aldosteronism Surgical Outcome (PASO) Criteria :
1. Complete Clinical Success:Blood pressure is completely normalized without the need for antihypertensive medications.
2. Partial Clinical Success:Blood pressure improves, requiring fewer antihypertensive medications or easier control.
3. Absent Clinical Success:No significant improvement in blood pressure, and medication requirements remain unchanged.
4. Complete Biochemical Success: Postoperative aldosterone-to-renin ratio normalizes, indicating full correction of aldosterone overproduction.
5. Partial Biochemical Success: Aldosterone levels decrease but do not fully normalize.
6. Absent Biochemical Success: No significant improvement in biochemical markers, suggesting persistent aldosterone overproduction.
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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