68Ga-FAPI PET/CT in Liver Fibrosis Patients (GFAPILF)

F

Fujian Medical University (FJMU)

Status and phase

Enrolling
Early Phase 1

Conditions

Liver Fibrosis
Positron Emission Tomography

Treatments

Drug: 68Ga-FAPI-04

Study type

Interventional

Funder types

Other

Identifiers

NCT04533828
FAPILF

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Weibing Miao, M.D.; Chao Huang

Data sourced from clinicaltrials.gov

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