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Trial Title:
Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue
NCT ID:
NCT05963035
Condition:
Clear Cell Sarcoma of Soft Tissue
Conditions: Official terms:
Sarcoma
Sarcoma, Clear Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-PFPN
Description:
For patients clinically suspected or confirmed clear cell sarcoma of soft tissue,
integrated PET/MR or PET/CT imaging will be performed using targeted melanin-specific
imaging agent 18F-PFPN. Meanwhile, multiple parameters will be compared with the general
imaging agent 18F-FDG.
Arm group label:
18F-PFPN PET
Other name:
18F-PEG3-FPN
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
PET/MR imaging will be performed. PET/CT 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 PET/MR or PET/CT 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 and/or 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 PET/MR imaging. PET/CT 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult patients (age 18 years or above), regardless of gender;
- Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue
(supporting evidence including visual examination, MRI, CT, ultrasound, and
histopathological examination, etc.) ;
- Patients who agree to undergo both 18F-PFPN and 18F-FDG PET imaging.
Exclusion Criteria:
- Acute systemic diseases and electrolyte disturbances;
- Patients who plan to get pregnant within six months or are pregnant or
breastfeeding;
- The patient or his/her legal representative is unable or unwilling to sign the
informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
China, Hubei Province
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoli Lan
Phone:
+86-027-83692633
Email:
lxl730724@hotmail.com
Start date:
June 21, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963035
