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

NCT04747561 | Unknown

• 1 other identifier: XLan-0016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of 18F-PEG3-FPN PET/MR for diagnosis and staging in melanoma.

  For subjects with suspected or diagnosed or treated melanoma who have completed 18F-FDG PET/CT imaging, diagnosis and staging results of 18F-PEG3-FPN PET/MR, PET/CT will be compared to 18F-FDG PET/CT imaging, pathology, clinical and follow-up result.

  up to 2 years

Study Arms (1)

18F-PEG3-FPN PET

EXPERIMENTAL

A positron probe for the targeted melanin

Drug: 18F-PEG3-FPN

Interventions

18F-PEG3-FPN DRUG

For clinically suspected or confirmed melanoma patients and healthy volunteers, integrated PET/MR imaging was performed using targeted melanin-specific imaging agent 18F-PEG3-FPN. Meanwhile, the general imaging agent 18F-FDG was compared with MR multi-sequence and multi-parameters

Also known as: 18F-FDG

18F-PEG3-FPN PET

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

China, Hubei Province

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Xiaoli Lan, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 10, 2021
• Study Start: January 12, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 21, 2023

Record last verified: 2022-02

Locations

CN (1)