MelanomaNCT05645484
The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma
An observational study of Melanoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma
- What is being tested?
- 18F-PFPN and 18F-FDG
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically highly suspected or confirmed melanoma underwent 18F-PFPN and 18F-FDG PET scans in the PET center.
Who may be able to join
- Patients with histopathologically confirmed melanoma;
- Patients with complete clinical and follow-up data (including TNM stage, subtypes, and treatment strategies).
Who cannot join
- Uncertain histopathology;
- A history of other malignancies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Hubei Province
Wuhan, Hubei, 430022
Xiaoli Lan, PhD, 0086-027-83692633, lxl730724@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- 18F-PFPN, 18F-FDG
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PFPNDrug
Also called 18F-PEG3-FPN
18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging.
18F-FDGDrug
Also called 18F-fluorodeoxyglucose
18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 years
Overall Survival (OS)
OS time is defined as the time from PET imaging to death or the endpoint of follow-up.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start2 Sep 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoli Lan, PhD, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645484
- Sponsor's protocol ID
- XLan-0624
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37191681
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma
- ClinicalTrials.gov ID
- NCT05645484
- Acronym / sponsor ID
- XLan-0624
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18F-PFPN PET imaging | – | Drug: 18F-PFPNFor 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-FDG PET imaging | – | Drug: 18F-FDGFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically highly suspected or confirmed melanoma underwent 18F-PFPN and 18F-FDG PET scans in the PET center.
Key inclusion criteria (2 listed)
- Patients with histopathologically confirmed melanoma;
- Patients with complete clinical and follow-up data (including TNM stage, subtypes, and treatment strategies).
Key exclusion criteria (2 listed)
- Uncertain histopathology;
- A history of other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-PFPNAlso: 18F-PEG3-FPN18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging. | Drug | 18F-PFPN PET imaging |
| 18F-FDGAlso: 18F-fluorodeoxyglucose18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging. | Drug | 18F-FDG PET imaging |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 37191681Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoli Lan, PhD study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Lan, PhD (0086-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 1-2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.