[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity

Sponsor
Jilin University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05806333
Collaborator
(none)
60
1
1
12
5

Study Details

Study Description

Brief Summary

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. We aim to conduct a prospective study to investigate the diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: FAPI PET
N/A

Detailed Description

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for visualizing CAFs. CAFs are crucial components of the tumor stroma, promote the growth of cancer cells, and are associated with poor prognosis. Currently, 18F-labelled fbroblast activation protein inhibitor 18F-FAPI has shown promising diagnostic value in many types of tumors, especially those in which are not avid for 18F-FDF , and several studies have demonstrated that 18F-FAPI PET/CT is superior to 18F-FDG PET/CT for detecting liver cancer and has lower tracer uptake in normal liver tissue. We aim to conduct a prospective study to investigate the diagnostic performance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Performance of [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: suspicious focal liver mass without FDG avidity

Experimental: 18F-FAPI PET/CT Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer

Diagnostic Test: FAPI PET
Drug: 18F-FAPI 18F-FAPI were injected into the patients before the PET/CT scans

Outcome Measures

Primary Outcome Measures

  1. Diagnostic performance of FAPI PET [1 year]

    Sensitivity and specificity in detecting liver cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with suspected liver malignant lesions based on traditional diagnostic imaging (CT or MRI or ultrasound) and clinical symptoms;

  • patients underwent [18F]FDG PET/CT with negative findings (suspicious primary and/or metastatic lesions were hypo- or isometabolic on [18F]FDG PET/CT);

  • patients who agreed to undergo [18F]FAPI PET/CT scans within 1 week.

Exclusion Criteria:
  • pregnancy;

  • age<18 years old;

  • patients with chemo/radio/targeted therapy before scanning;

  • inability to provide informed consent (signed by participant, parent, or legal representative).

Contacts and Locations

Locations

Site City State Country Postal Code
1 China-Japan Union Hospital Chang chun Jilin China 130031

Sponsors and Collaborators

  • Jilin University

Investigators

  • Principal Investigator: Bin Ji, China-Japan Union Hospital, Jilin University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ji Bin, PHD, Jilin University
ClinicalTrials.gov Identifier:
NCT05806333
Other Study ID Numbers:
  • ChinaJapanUH
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023