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Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue

Primary Purpose

Clear Cell Sarcoma of Soft Tissue

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-PFPN
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Clear Cell Sarcoma of Soft Tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China, Hubei ProvinceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-PFPN PET

Arm Description

A positron probe for the targeted melanin

Outcomes

Primary Outcome Measures

Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue
18F-PFPN and 18F-FDG PET/MR or PET/CT images will be analyzed by at least 2 physicians experienced in nuclear medicine and radiology. The general information, clinical, histopathological and imaging data of patients will be collected and analyzed to calculate the sensitivity and specificity of 18F-PFPN for diagnosis and staging in clear cell sarcoma of soft tissue.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2023
Last Updated
July 19, 2023
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05963035
Brief Title
Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue
Official Title
Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Sarcoma of Soft Tissue

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-PFPN PET
Arm Type
Experimental
Arm Description
A positron probe for the targeted melanin
Intervention Type
Drug
Intervention Name(s)
18F-PFPN
Other Intervention Name(s)
18F-PEG3-FPN
Intervention 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.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue
Description
18F-PFPN and 18F-FDG PET/MR or PET/CT images will be analyzed by at least 2 physicians experienced in nuclear medicine and radiology. The general information, clinical, histopathological and imaging data of patients will be collected and analyzed to calculate the sensitivity and specificity of 18F-PFPN for diagnosis and staging in clear cell sarcoma of soft tissue.
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Lan
Phone
0086-027-83692633
Email
lxl730724@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoli Lan
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
Facility Information:
Facility Name
China, Hubei Province
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoli Lan
Phone
+86-027-83692633
Email
lxl730724@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue

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