Clinical Trial · NCT04747561

Clinical Application of 18F-PEG3-FPN PET Imaging in Diagnosis and Staging of Malignant Melanoma

Overview

This study is a diagnostic study. Patients and healthy volunteers were recruited from clinically suspected or confirmed melanoma patients to undergo 18F-PEG3-FPN PET/MR or PET/CT imaging to observe the response of the subjects after drug injection, and evaluate the efficacy of 18F-PEG3-FPN PET imaging in the diagnosis and staging of melanoma compared with 18F-FDG PET imaging. PET/CT imaging was performed in patients with contraindications to MR. The subjects underwent 18F-PEG3-FPN and 18F-FDG PET/MR or PET/CT imaging at an interval of two days, respectively. The general information, clinical data, blood routine, liver and kidney function indexes, 18F-PEG3-FPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the patients and volunteers were collected, and the histopathology of biopsy or surgical specimen was taken as the final diagnostic criteria. This study plans to set the sample size as 50 cases.

Sponsor

Norwegian University of Science and Technology

Phase

N/A

Contacts

Xiaoli Lan, PhD (STUDY_DIRECTOR)

Xiaoli Lan, PhD (CONTACT)

lxl730724@hotmail.com

0086-027-83692633

ClinicalTrials.gov

NCT04747561

Drug / Compound

FDG

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

PEG3-FPN

Isotope(s):

Target(s):

MC1R

Ligand Class: Small Molecules

Linker: PEG3

Eligibility

Inclusion

* Adult patients (age 18 years or above), regardless of gender；
Patients with clinically suspected or confirmed melanoma (supporting evidence including visual examination, MRI, CT, ultrasound, and histomathological examination, etc.) who agree to undergo histomathological examination (if not performed before imaging) and 18F-FDG PET imaging;Healthy volunteers;
The patient or his legal representative can sign the informed consent.

Exclusion

* Acute systemic diseases and electrolyte disturbances;
The patient or his legal representative is unable or unwilling to sign the informed consent.
Pregnant or lactating women;