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Trial Title:
The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma
NCT ID:
NCT05645484
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Fluorodeoxyglucose F18
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
18F-PFPN
Description:
18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging.
Arm group label:
18F-PFPN PET imaging
Other name:
18F-PEG3-FPN
Intervention type:
Drug
Intervention name:
18F-FDG
Description:
18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging.
Arm group label:
18F-FDG PET imaging
Other name:
18F-fluorodeoxyglucose
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.
Criteria for eligibility:
Study pop:
Patients with clinically highly suspected or confirmed melanoma underwent 18F-PFPN and
18F-FDG PET scans in the PET center.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China, Hubei Province
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoli Lan, PhD
Phone:
0086-027-83692633
Email:
lxl730724@hotmail.com
Start date:
September 2, 2022
Completion date:
August 31, 2023
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05645484
