Clinical trial NCT05264688: The Function of PET Molecular Imaging Targeting Fibroblast Activation Protein in the Hepatobiliary Malignancies
Official title: The Role of Novel PET Molecular Imaging Targeting Fibroblast Activation Protein in the Diagnosis of Hepatobiliary Malignancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatobiliary Diseases
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high clinical suspicion of hepatobiliary malignancies and meeting the inclusion and exclusion criteria

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.

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

Primary outcomes:
measure: diagnose accordance rate
timeFrame: 2022.1.20-2022.7.30
Secondary outcomes:
measure: Standardized Uptake Mean (SUVmean)
timeFrame: 2022.1.20-2022.7.30
measure: Standardized Uptake Maximum (SUVmax)
timeFrame: 2022.1.20-2022.7.30
measure: Tumor Background Ratio
timeFrame: 2022.1.20-2022.7.30
measure: Tumor Metabolic Volume (MTV)
timeFrame: 2022.1.20-2022.7.30
measure: Total Glycolysis (TLG)
timeFrame: 2022.1.20-2022.7.30
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital
state: Hubei
Study officials:
References: