Clinical Application of 18F-PEG3-FPN PET Imaging in Diagnosis and Staging of Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT04747561|
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: 18F-PEG3-FPN||Not Applicable|
This team always picolinamide structure based, successfully synthesized a positron nuclide targeting melanin probe - 18-5 - f FPN [18 f - 5 - fluoro - N - (2 - (diethyl amino) ethyl) pyridine formamide] for PET imaging, we found that combining FPN and melanin with high specificity and favorable pharmacokinetic characteristics, can be sensitive to detect the tiny metastases (lung, lymph node metastasis), which shows good potential of PET imaging for melanoma.The preparation method of 18F-5-FPN is simple and can be directly synthesized and purified by GE's synthesis module automatically.Then, we optimized the probe with triethylene glycol (PEG3), 18F-PEG3-FPN, to improve the labeling rate of the probe (44.68% >;6.98%, 18F-5-FPN), reduced its uptake in the liver, improved its drug distribution in vivo, and was successfully applied in the detection of liver metastasis.The integrated TOF PET/MR imaging equipment is the most advanced imaging equipment at present, which combines the advantages of PET and MR. With the high sensitivity of PET and the high soft tissue contrast of MR, it has obvious advantages over PET/CT in head, neck, abdomen and pelvic lesions.
At the same time, MR has no additional radiation and is more biosafety. With 18 f - PEG3 - FPN in clinical potential of melanoma imaging, 18 f - this project intends to apply PEG3 - FPN integrated PET/MR imaging diagnosis and staging of malignant melanoma tumors and clinical use of 18 f - FDG PET/CT imaging contrast, design of a prospective study, explore 18 f - PEG3 - FPN detection performance of melanoma, to make up for 18 f - FDG PET imaging diagnosis and staging of melanoma value.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Application of 18F-PEG3-FPN PET Imaging in Diagnosis and Staging of Malignant Melanoma|
|Actual Study Start Date :||January 12, 2021|
|Estimated Primary Completion Date :||January 12, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: 18F-PEG3-FPN PET
A positron probe for the targeted melanin
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
Other Name: 18F-FDG
- Sensitivity and specificity of 18F-PEG3-FPN PET/MR for diagnosis and staging in melanoma. [ Time Frame: up to 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747561
|Contact: Xiaoli Lan, PhDemail@example.com|
|China, Hubei Province||Recruiting|
|Wuhan, Hubei, China, 430022|
|Contact: Xiaoli Lan 0086-027-83692633 firstname.lastname@example.org|
|Study Director:||Xiaoli Lan, PhD||Wuhan Union Hospital, China|