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

Recruiting

• Conditions: Melanoma
• Interventions: Drug: 18F-PFPN; Drug: 18F-FDG

• Registration Number: NCT05645484
• Lead Sponsor: Wuhan Union Hospital, China

Brief 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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-02
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-09
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with histopathologically confirmed melanoma;
• Patients with complete clinical and follow-up data (including TNM stage, subtypes, and treatment strategies).

Exclusion Criteria

• Uncertain histopathology;
• A history of other malignancies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
18F-PFPN PET imaging	18F-PFPN	For clinically suspected or confirmed melanoma patients, targeted melanin-specific imaging 18F-PFPN PET/MR was performed. CT was instead when MRI was contraindicated. PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses.
18F-FDG PET imaging	18F-FDG	For clinically suspected or confirmed melanoma patients, general metabolic imaging 18F-FDG PET PET/CT was performed. PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	1-2 years	PFS time is calculated from the date of PET imaging to the first recurrence/progression or death or the endpoint of follow-up. The disease recurrence/progression is confirmed after a thorough review of following-up imaging or pathologic findings.
Overall Survival (OS)	1-2 years	OS time is defined as the time from PET imaging to death or the endpoint of follow-up.

Trial Locations

Locations (1)

China, Hubei Province; 🇨🇳 Wuhan, Hubei, China