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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatobiliary Diseases
• Intervention / Treatment: Diagnostic test: 68Ga-FAPI-04 imaging agent

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Yufeng Yuan; Phone Number: 13995564795; Email: yuanyf1971@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Zhongnan Hospital
      • Contact: Yufeng Yuan; Email: yuanyf1971@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with high clinical suspicion of hepatobiliary malignancies and meeting the inclusion and exclusion criteria

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Liver Diseases; Digestive System Diseases
• Other Study ID Numbers: 20220207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No