NCT05806333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 8, 2023

Last Update Submit

March 28, 2023

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of FAPI PET

    Sensitivity and specificity in detecting liver cancer

    1 year

Study Arms (1)

suspicious focal liver mass without FDG avidity

EXPERIMENTAL

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

Diagnostic Test: FAPI PET

Interventions

FAPI PETDIAGNOSTIC_TEST

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

suspicious focal liver mass without FDG avidity

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Union Hospital

Changchun, Jilin, 130031, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Bin Ji

    China-Japan Union Hospital, Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi Gao [gshi]

CONTACT

+86-84995467Gaoshi@jlu.edu.cn

Ji Bin [jbin]

CONTACT

+86-15143066521jibin1983104@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 10, 2023

Study Start

June 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 10, 2023

Record last verified: 2023-03

Locations

CN(1)