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

NCT ID: NCT05264688

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2022-10-31

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.

Conditions

Hepatobiliary Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

68Ga-FAPI-04 imaging agent

1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg) intravenously

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yufeng Yuan

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongnan Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yufeng Yuan

Role: CONTACT

yuanyf1971@whu.edu.cn

13995564795

Facility Contacts

Yufeng Yuan

Role: primary

yuanyf1971@whu.edu.cn

Other Identifiers

20220207

Identifier Type: -

Identifier Source: org_study_id