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RecruitingNCT04831034Updated Sep 21, 2023

68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease

An Early Phase 1 interventional study of 68Ga-FAPI-04 in Fibrosis and Positron-Emission Tomography, sponsored by First Affiliated Hospital of Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by First Affiliated Hospital of Fujian Medical University · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2021; still recruiting 5 years 6 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the detailed description

Subjects with fibrotic disease underwent 68Ga-FAPI-04 PET/CT scanning. Fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as magnetic resonance imaging(MRI) , biopsy 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, MRI and BBI were calculated and compared to evaluate the diagnostic efficacy.

02

Conditions studied

  • Fibrosis
  • Positron-Emission Tomography

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03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 466 are open to participants now.

This study's planned enrollment of 500 is above the median of 50 across 2,130 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

First Affiliated Hospital of Fujian Medical University is the lead sponsor of 92 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adult patients (aged 18 years or order)
  • patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , 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

Exclusion Criteria:

  • patients with pregnancy
  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    68Ga-FAPI-04

    Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.

    Drug: 68Ga-FAPI-04

Interventions

  • Drug68Ga-FAPI-04

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

06

What researchers measure

Primary outcomes

  1. Standardized uptake value (SUV)

    Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject.

    Time frame: 30 days

Secondary outcomes

  1. Diagnostic efficacy

    The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian 350005, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04831034
Lead sponsor
First Affiliated Hospital of Fujian Medical University
Responsible party
Weibing Miao, PhD (Director, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University) — Principal investigator
First posted
Apr 5, 2021
Start date
Apr 1, 2021
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Sep 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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