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

Hepatobiliary Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264688
• Other study ID #: 20220207
• Status: Recruiting
• Start date: January 20, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2022
• Source: Zhongnan Hospital
• Contact: Yufeng Yuan
• Phone: 13995564795
• Email: yuanyf1971[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Hepatobiliary Diseases
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
China	Zhongnan Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnose accordance rate	Proportion of PET/CT diagnostic reports consistent with pathological results	2022.1.20-2022.7.30
Secondary	Standardized Uptake Mean (SUVmean)	The average of the standard uptake value	2022.1.20-2022.7.30
Secondary	Standardized Uptake Maximum (SUVmax)	The maximum value of the standard uptake value	2022.1.20-2022.7.30
Secondary	Tumor Background Ratio	The ratio of the radiation concentration in the tumor area to the surrounding background	2022.1.20-2022.7.30
Secondary	Tumor Metabolic Volume (MTV)	The metabolically active volume of tumor tissue	2022.1.20-2022.7.30
Secondary	Total Glycolysis (TLG)	Tumor metabolic volume is multiplied by the mean of standard uptake	2022.1.20-2022.7.30