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

July 19, 2023 updated by: Wuhan Union Hospital, China
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • China, Hubei Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-PFPN PET
A positron probe for the targeted melanin
Drug: 18F-PFPN
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.
Other Names:
  • 18F-PEG3-FPN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue
Time Frame: 1 years
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.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Study Director: Xiaoli Lan, Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XLan-0409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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