drugset / Trial / NCT04747561

Clinical Application of 18F-PEG3-FPN PET Imaging in Diagnosis and Staging of Malignant Melanoma

NCT04747561

NaSingle-groupOpen-labelDiagnostic

Summary

This study is a diagnostic study. Patients and healthy volunteers were recruited from clinically suspected or confirmed melanoma patients to undergo 18F-PEG3-FPN PET/MR or PET/CT imaging to observe the response of the subjects after drug injection, and evaluate the efficacy of 18F-PEG3-FPN PET imaging in the diagnosis and staging of melanoma compared with 18F-FDG PET imaging. PET/CT imaging was performed in patients with contraindications to MR. The subjects underwent 18F-PEG3-FPN and 18F-FDG PET/MR or PET/CT imaging at an interval of two days, respectively. The general information, clinical data, blood routine, liver and kidney function indexes, 18F-PEG3-FPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the patients and volunteers were collected, and the histopathology of biopsy or surgical specimen was taken as the final diagnostic criteria. This study plans to set the sample size as 50 cases.

Timeline

Start
2021-01-12
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-FDG Diagnostic / imaging agent

Indications