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

• Conditions: Hepatobiliary Diseases

• Registration Number: NCT05264688
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27
• Primary Completion: 2022-07-30
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnose accordance rate	2022.1.20-2022.7.30	Proportion of PET/CT diagnostic reports consistent with pathological results

Secondary Outcome Measures

Name	Time	Method
Tumor Background Ratio	2022.1.20-2022.7.30	The ratio of the radiation concentration in the tumor area to the surrounding background
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 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

Trial Locations

Locations (1)

Zhongnan Hospital; 🇨🇳 Wuhan, Hubei, China