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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645484
• Other study ID #: XLan-0624
• Status: Recruiting
• Start date: September 2, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2022
• Source: Wuhan Union Hospital, China
• Contact: Xiaoli Lan, PhD
• Phone: 0086-027-83692633
• Email: lxl730724[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• 18F-PFPN
18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging.
• 18F-FDG
18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging.

Locations

Country	Name	City	State
China	China, Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall Survival (OS)	OS time is defined as the time from PET imaging to death or the endpoint of follow-up.	1-2 years