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Recruiting NCT07464132

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

Phase I / Phase II Interventional Tumor Cardiovascular Diseases Pulmonary Fibrosis Rheumatic Immune Diseases Involving Large Blood Vessels

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injection of 68Ga-NI-FAPI.
Who it may be relevant to
Registry conditions: Tumor, Cardiovascular Diseases, Pulmonary Fibrosis, Rheumatic Immune Diseases Involving Large Blood Vessels. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union — Beijing

Identifiers

NCT: NCT07464132 · I-25PJ0568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗