search
Back to results

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

Primary Purpose

Liver Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FAPI PET
Sponsored by
Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • China-Japan Union HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

suspicious focal liver mass without FDG avidity

Arm Description

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

Outcomes

Primary Outcome Measures

Diagnostic performance of FAPI PET
Sensitivity and specificity in detecting liver cancer

Secondary Outcome Measures

Full Information

First Posted
March 8, 2023
Last Updated
March 28, 2023
Sponsor
Jilin University
search

1. Study Identification

Unique Protocol Identification Number
NCT05806333
Brief Title
[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
Official Title
Diagnostic Performance of [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jilin University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
suspicious focal liver mass without FDG avidity
Arm Type
Experimental
Arm Description
Experimental: 18F-FAPI PET/CT Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer
Intervention Type
Diagnostic Test
Intervention Name(s)
FAPI PET
Intervention Description
Drug: 18F-FAPI 18F-FAPI were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Diagnostic performance of FAPI PET
Description
Sensitivity and specificity in detecting liver cancer
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shi Gao [gshi]
Phone
+86-84995467
Email
Gaoshi@jlu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Bin [jbin]
Phone
+86-15143066521
Email
jibin1983104@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Ji
Organizational Affiliation
China-Japan Union Hospital, Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Union Hospital
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wei
Phone
+8684995117
Email
Weijunsy1949@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs