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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Melanoma

Intervention / Treatment
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* Drug: 18F-PFPN
* Drug: 18F-FDG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 18F-PFPN PET imaging<br>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. | Drug: 18F-PFPN<br>* 18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging.<br>* Other names: 18F-PEG3-FPN;|
| 18F-FDG PET imaging<br>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. | Drug: 18F-FDG<br>* 18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging.<br>* Other names: 18F-fluorodeoxyglucose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | 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. | 1-2 years | 
| Overall Survival (OS) | OS time is defined as the time from PET imaging to death or the endpoint of follow-up. | 1-2 years |