Recruiting

NCT Number: NCT07464132

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

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.

Recruiting

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Key information

Conditions

Tumor Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Fibrosis Heart Diseases Heart Valve Diseases Hypertrophic Cardiomyopathy (HCM) Lung Diseases Lung Diseases, Interstitial Neoplasms Other Hypoxic and Fibroblast Activated Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases Rheumatic Immune Diseases Involving Large Blood Vessels

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Wang

CONTACT

[email protected]

+86-13021115973

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of 68Ga-NI-FAPI

Drug

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

Primary outcomes

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

Time frame: Within 30-120 minutes after intravenous injection of imaging agent

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhu

CONTACT

[email protected]

+86-13021115973

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 11, 2026
Registry last updated: Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed