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

NCT ID: NCT05806333

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Liver Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

FAPI PET

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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FAPI PET

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Ji Bin

PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Ji

Role: PRINCIPAL_INVESTIGATOR

China-Japan Union Hospital, Jilin University

Locations

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China-Japan Union Hospital

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shi Gao [gshi]

Role: CONTACT

+86-84995467

Ji Bin [jbin]

Role: CONTACT

+86-15143066521

Facility Contacts

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Jun Wei

Role: primary

+8684995117

Other Identifiers

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ChinaJapanUH

Identifier Type: -

Identifier Source: org_study_id

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