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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-02

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

18F-PFPN

Intervention Type DRUG

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

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.

18F-FDG

Intervention Type DRUG

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

Interventions

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18F-PFPN

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

Intervention Type DRUG

18F-FDG

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

Intervention Type DRUG

Other Intervention Names

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18F-PEG3-FPN 18F-fluorodeoxyglucose

Eligibility Criteria

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Inclusion Criteria

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