Application of Al18F-NOTA-Pentixafor PET/CT for 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
Peking Union Medical College Hospital
150 participants
Dec 30, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria7
- 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.
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Interventions
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.
Locations(1)
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NCT06773663