The Function of PET Molecular Imaging Targeting Fibroblast Activation Protein in the Hepatobiliary Malignancies

Study Overview
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Brief Summary
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Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week, and collect tumor tissue. Finally, the PET/CT results were compared with the pathology report to evaluate the role of 68Ga-FAPI PET/CT imaging in the diagnosis of hepatobiliary malignancies

Detailed Description
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Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week. After comprehensive clinical evaluation, if the patient can be treated with surgery, surgery will be performed, and the patient's pathological specimens will be collected after surgery ; If the patient has no possibility of surgery, ultrasound-guided needle biopsy is performed, and biopsy specimens are collected. Finally, the PET/CT results were compared with the pathology report to evaluate the application value of 68Ga-FAPI PET/CT imaging in the diagnosis and staging of hepatobiliary malignant tumors, and to analyze the guiding significance for the treatment decision of hepatobiliary malignant tumors.

Official Title
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The Role of Novel PET Molecular Imaging Targeting Fibroblast Activation Protein in the Diagnosis of Hepatobiliary Malignancies

Conditions
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Hepatobiliary Diseases

Intervention / Treatment
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* Diagnostic Test: 68Ga-FAPI-04 imaging agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily participate and sign a written informed consent; 18-80 years old (inclusive) male or female; Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc. Those who obtained pathological diagnosis results through needle biopsy or surgical resection; Have willingness and ability to participate in all research procedures. Exclusion Criteria: Women who are pregnant or breastfeeding; Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients; Those who have a history of other malignant tumors in the past; Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L; Patients with claustrophobia; Those who cannot tolerate lying down for 15-30 minutes; The researchers believe that it is not suitable to participate in this clinical trial; Those who have participated in clinical trials or are participating in other clinical trials within the past month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 68Ga-FAPI-04 imaging agent|1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg) intravenously|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnose accordance rate | Proportion of PET/CT diagnostic reports consistent with pathological results | 2022.1.20-2022.7.30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Uptake Mean (SUVmean) | The average of the standard uptake value | 2022.1.20-2022.7.30 | 
| Standardized Uptake Maximum (SUVmax) | The maximum value of the standard uptake value | 2022.1.20-2022.7.30 | 
| Tumor Background Ratio | The ratio of the radiation concentration in the tumor area to the surrounding background | 2022.1.20-2022.7.30 | 
| Tumor Metabolic Volume (MTV) | The metabolically active volume of tumor tissue | 2022.1.20-2022.7.30 | 
| Total Glycolysis (TLG) | Tumor metabolic volume is multiplied by the mean of standard uptake | 2022.1.20-2022.7.30 |