The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma
February 18, 2023 updated by: Wuhan Union Hospital, China
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Recruiting
- China, Hubei Province
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 (dose: 3.0-5.4
MBq/kg) will be injected intravenously prior to imaging.
Other Names:
|
|
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 (dose: 3.7-5.4
MBq/kg) will be injected intravenously prior to imaging.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free Survival (PFS)
Time Frame: 1-2 years
|
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)
Time Frame: 1-2 years
|
OS time is defined as the time from PET imaging to death or the endpoint of follow-up.
|
1-2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2022
Primary Completion (Anticipated)
August 31, 2023
Study Completion (Anticipated)
August 31, 2023
Study Registration Dates
First Submitted
December 2, 2022
First Submitted That Met QC Criteria
December 2, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 18, 2023
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XLan-0624
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.