Melanoma
Conditions
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.
Interventions
DRUG18F-PFPN
18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging.
DRUG18F-FDG
18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXiaoli Lan, PhD
Outcome results
None listed