68Ga-FAPI PET/CT in Liver Fibrosis Patients

NCT ID: NCT04533828

Last Updated: 2020-09-03

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

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-12-30

Brief Summary

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To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis and prognosis in liver fibrosis disease.

Detailed Description

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Subjects with liver fibrosis underwent 68Ga-FAPI-04 PET/CT scanning. Liver fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as transient elastography (TE) and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, TE and BBI were calculated and compared to evaluate the diagnostic efficacy.

Conditions

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Liver Fibrosis Positron Emission Tomography

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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68Ga-FAPI-04 PET/CT scanning

Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.

Group Type EXPERIMENTAL

68Ga-FAPI-04

Intervention Type DRUG

Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.

Interventions

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68Ga-FAPI-04

Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients (aged 18 years or order)
* patients with suspected or new diagnosed or previously treated liver fibrosis (supporting evidence may include TE, BBI, MRI, CT and pathology report)
* patients who had scheduled 68Ga-FAPI-04 PET/CT scan
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria

* patients without liver fibrosis lesions
* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weibing Miao, PhD

Director, Department of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibing Miao, M.D.

Role: CONTACT

86-591-87981618

Chao Huang

Role: CONTACT

86-591-87981619

Facility Contacts

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Weibing Miao, M.D.

Role: primary

86-591-87981618

Chao Huang

Role: backup

86-591-87981619

Other Identifiers

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FAPILF

Identifier Type: -

Identifier Source: org_study_id

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