Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963035
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-19
Brief Title:
Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective monocentric study aimed to evaluate the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited and 18F-PFPN PETMR imaging will be performed PETCT imaging will be performed in patients with contraindications to MR Additionally to compare the diagnostic efficacy with the traditional imaging agent 18F-FDG patients will also undergo 18F-FDG PET imaging and the two imaging intervals will be completed two days apart The general information clinical data 18F-PFPN and 18F-FDG PETMR or PETCT imaging results and other imaging data of the patients will be collected The histopathology of the biopsy or surgical specimen follow-up and other imaging examinations will be taken as evaluation references This study plans to set the sample size as 10 cases
Detailed Description:
Clear cell sarcoma of soft tissue is a rare malignancy derived from neural crest cells that contain melanin andor melanin precursors Melanin is an important target for the diagnosis of clear cell sarcoma of soft tissue 18F-PFPN a highly specific melanin-targeting positron probe has been proven to have excellent pharmacokinetic properties and good biological safety and can sensitively detect tiny melanin-containing lesions Therefore 18F-PFPN PET imaging is expected to be used in diagnosing and staging clear cell sarcoma of soft tissue
This study was designed as a prospective study to explore the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue In this study patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited to undergo 18F-PFPN PETMR imaging PETCT imaging will be performed in patients with contraindications to MR The general information clinical data imaging data and histopathology results of patients will be collected The efficiency of diagnosis and staging of 18F-PFPN was evaluated by comparing the gold standard pathological diagnosis and the general metabolic imaging agent 18F-FDG
This study was designed as a prospective study to explore the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue In this study patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited to undergo 18F-PFPN PETMR imaging PETCT imaging will be performed in patients with contraindications to MR The general information clinical data imaging data and histopathology results of patients will be collected The efficiency of diagnosis and staging of 18F-PFPN was evaluated by comparing the gold standard pathological diagnosis and the general metabolic imaging agent 18F-FDG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None