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

NCT05645484 | Unknown

• 1 other identifier: XLan-0624
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• 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

• Overall Survival (OS)

  OS time is defined as the time from PET imaging to death or the endpoint of follow-up.

  1-2 years

Study Arms (2)

18F-PFPN PET imaging

For clinically suspected or confirmed melanoma patients, targeted melanin-specific imaging 18F-PFPN PET/MR was performed. CT was instead when MRI was contraindicated. PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses.

Drug: 18F-PFPN

18F-FDG PET imaging

For clinically suspected or confirmed melanoma patients, general metabolic imaging 18F-FDG PET PET/CT was performed. PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses.

Drug: 18F-FDG

Interventions

18F-PFPN DRUG

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

Also known as: 18F-PEG3-FPN

18F-PFPN PET imaging

18F-FDG DRUG

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

Also known as: 18F-fluorodeoxyglucose

18F-FDG PET imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically highly suspected or confirmed melanoma underwent 18F-PFPN and 18F-FDG PET scans in the PET center.

You may qualify if:

• Patients with histopathologically confirmed melanoma;
• Patients with complete clinical and follow-up data (including TNM stage, subtypes, and treatment strategies).

You may not qualify if:

• Uncertain histopathology;
• A history of other malignancies.

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

Related Publications (1)

• Zhang X, Lin Z, Li M, Gai Y, Zheng H, Fan L, Ruan W, Hu F, Chen J, Lan X. Melanin-targeted [18F]-PFPN PET imaging for prognosticating patients with melanoma. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3062-3071. doi: 10.1007/s00259-023-06258-5. Epub 2023 May 16.

  PMID: 37191681 DERIVED

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 9, 2022
• Study Start: September 2, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 21, 2023

Record last verified: 2022-09

Locations

CN (1)