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

NCT07464132 | Recruiting Phase 1

• 1 other identifier: I-25PJ0568
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04

  Semi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)

  Within 30-120 minutes after intravenous injection of imaging agent

Study Arms (1)

NI-FAPI group

EXPERIMENTAL

Injection of \[68Ga\]Ga-NI-FAPI

Drug: Injection of 68Ga-NI-FAPI

Interventions

Injection of 68Ga-NI-FAPI DRUG

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

NI-FAPI group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases; Pulmonary Fibrosis; Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Heart Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Zhu

CONTACT

+86-13021115973; yfwyw1999@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 11, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): February 17, 2027
• Study Completion (Estimated): June 17, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)