NCT05645484

The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a monocentric prospective study. This study aims to investigate the prognostic value of the novel melanin-targeted imaging modality 18F-PFPN PET in patients with melanoma and seek independent prognostic factors for progression-free survival (PFS) and overall survival (OS). The patients with clinically highly suspected or confirmed melanoma who underwent 18F-PFPN and 18F-FDG PET scans will be enrolled consecutively. Patients' PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses. This study plans to set the sample size as 100 cases.

Detailed description

Melanoma is an aggressive malignancy with a high mortality rate. Accurate diagnosis and prognostic risk assessment are essential to the clinical management of melanoma. Melanin is present in most melanoma and has become a potential target for melanoma. This team has successfully synthesized a positron nuclide targeting melanin probe named 18F-PFPN (18F-N-(2-diethylaminoethyl)-4-(2-\[2-ethoxy\]-ethoxy) pyridine), which has been proven to be safe and well-tolerated. It has shown excellent diagnostic value in both primary and metastatic melanoma. This prospective study was designed to further investigate the prognostic value of 18F-PFPN for melanoma and compare it with the general metabolic imaging agent 18F-FDG. In this study, patients with clinically highly suspected or confirmed melanoma who underwent 18F-PFPN and 18F-FDG PET scans will be enrolled consecutively. Patients' PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	18F-PFPN	18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging.
DRUG	18F-FDG	18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging.

Timeline

• Start date: 2022-09-02
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2022-12-09
• Last updated: 2023-02-21

Locations

1 site across 1 country: China