Trials / Unknown
UnknownNCT04533828
68Ga-FAPI PET/CT in Liver Fibrosis Patients
Value of 68Ga-FAPI-04 PET/CT for Diagnosis and Prognostic Evaluation in Liver Fibrosis
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- First Affiliated Hospital of Fujian Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
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
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga-FAPI-04 | Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2023-08-31
- Completion
- 2023-12-30
- First posted
- 2020-09-01
- Last updated
- 2020-09-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04533828. Inclusion in this directory is not an endorsement.