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

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07464132
Enrollment
30
Registered
2026-03-11
Start date
2025-12-17
Completion date
2027-06-17
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DRUGInjection of 68Ga-NI-FAPI

Subjects were injected with 68Ga-NI-FAPI at 0.4-0.5mci/kg body weight

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* 1: 18-85 years old 2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis 3: Ability to understand and sign informed consent forms 4: Expected survival period exceeding 6 months and able to receive follow-up 5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc

Exclusion criteria

* 1: Pregnant or lactating women 2: Patients allergic to research drug ingredients 3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L) 4: Patients who participate in other clinical trials and interfere with the results of this study 5: Patients with severe illness who cannot cooperate with the examination

Design outcomes

Primary

MeasureTime frameDescription
Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04Within 30-120 minutes after intravenous injection of imaging agentSemi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)

Countries

China

Contacts

CONTACTZhu
yfwyw1999@126.com+86-13021115973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026