The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- 18F-PFPN
- Conditions
- Melanoma
- Sponsor
- Wuhan Union Hospital, China
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
18F-PFPN PET imaging
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.
Intervention: 18F-PFPN
18F-FDG PET imaging
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.
Intervention: 18F-FDG
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: 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)
Time Frame: 1-2 years
OS time is defined as the time from PET imaging to death or the endpoint of follow-up.