Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07464132
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Hypertrophic Cardiomyopathy (HCM)
  • Other Hypoxic and Fibroblast Activated Diseases
  • Pulmonary Fibrosis
  • Rheumatic Immune Diseases Involving Large Blood Vessels
  • Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Injection of 68Ga-NI-FAPI — DRUG
    Subjects were injected with 68Ga-NI-FAPI at 0.4-0.5mci/kg body weight

Study Details

The purpose of this study is to conduct clinical research on \[68Ga\] Ga-NI-FAPI-04 PET/CT imaging and further investigate its diagnostic value in fibroblast activation related diseases.

Key Dates

Start date
Dec 17, 2025
Status verified
Mar 2026
Primary completion
Feb 17, 2027
Completion
Jun 17, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: NI-FAPI group
    Injection of \[68Ga\]Ga-NI-FAPI

Primary Outcome Measure

Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04 [ Time Frame: Within 30-120 minutes after intravenous injection of imaging agent ]

Central Contacts

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