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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
Sponsor:
Information provided by (Responsible Party):
Wuhan Union Hospital, China

Brief Summary:
This study is a diagnostic study. Patients and healthy volunteers were recruited from clinically suspected or confirmed melanoma patients to undergo 18F-PEG3-FPN PET/MR or PET/CT imaging to observe the response of the subjects after drug injection, and evaluate the efficacy of 18F-PEG3-FPN PET imaging in the diagnosis and staging of melanoma compared with 18F-FDG PET imaging. PET/CT imaging was performed in patients with contraindications to MR. The subjects underwent 18F-PEG3-FPN and 18F-FDG PET/MR or PET/CT imaging at an interval of two days, respectively. The general information, clinical data, blood routine, liver and kidney function indexes, 18F-PEG3-FPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the patients and volunteers were collected, and the histopathology of biopsy or surgical specimen was taken as the final diagnostic criteria. This study plans to set the sample size as 50 cases.

Condition or disease Intervention/treatment Phase
Melanoma Drug: 18F-PEG3-FPN Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: 18F-PEG3-FPN PET
A positron probe for the targeted melanin
Drug: 18F-PEG3-FPN
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients (age 18 years or above), regardless of gender;
  • Patients with clinically suspected or confirmed melanoma (supporting evidence including visual examination, MRI, CT, ultrasound, and histomathological examination, etc.) who agree to undergo histomathological examination (if not performed before imaging) and 18F-FDG PET imaging;Healthy volunteers;
  • The patient or his legal representative can sign the informed consent.

Exclusion Criteria:

  • Acute systemic diseases and electrolyte disturbances;
  • Pregnant or lactating women;
  • The patient or his legal representative is unable or unwilling to sign the informed consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaoli Lan, PhD 0086-027-83692633 lxl730724@hotmail.com

Locations
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China, Hubei
China, Hubei Province Recruiting
Wuhan, Hubei, China, 430022
Contact: Xiaoli Lan    0086-027-83692633    lxl730724@hotmail.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Study Director: Xiaoli Lan, PhD Wuhan Union Hospital, China
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Responsible Party: Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04747561    
Other Study ID Numbers: XLan-0016
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Fluorodeoxyglucose F18
Radiopharmaceuticals