Hepatobiliary Diseases
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TEST68Ga-FAPI-04 imaging agent
1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg) intravenously
Sponsors
Zhongnan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate and sign a written informed consent; 2. 18-80 years old (inclusive) male or female; 3. Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc. 4. Those who obtained pathological diagnosis results through needle biopsy or surgical resection; 5. Have willingness and ability to participate in all research procedures.
Exclusion criteria
1. Women who are pregnant or breastfeeding; 2. Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients; 3. Those who have a history of other malignant tumors in the past; 4. Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L; 5. Patients with claustrophobia; 6. Those who cannot tolerate lying down for 15-30 minutes; 7. The researchers believe that it is not suitable to participate in this clinical trial; 8. Those who have participated in clinical trials or are participating in other clinical trials within the past month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnose accordance rate | 2022.1.20-2022.7.30 | Proportion of PET/CT diagnostic reports consistent with pathological results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Mean (SUVmean) | 2022.1.20-2022.7.30 | The average of the standard uptake value |
| Standardized Uptake Maximum (SUVmax) | 2022.1.20-2022.7.30 | The maximum value of the standard uptake value |
| Tumor Background Ratio | 2022.1.20-2022.7.30 | The ratio of the radiation concentration in the tumor area to the surrounding background |
| Tumor Metabolic Volume (MTV) | 2022.1.20-2022.7.30 | The metabolically active volume of tumor tissue |
| Total Glycolysis (TLG) | 2022.1.20-2022.7.30 | Tumor metabolic volume is multiplied by the mean of standard uptake |
Countries
China
Contacts
Primary ContactYufeng Yuan
Outcome results
None listed