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

NCT05264688 | Unknown

• 1 other identifier: 20220207
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatobiliary Diseases

Outcome Measures

Primary Outcomes (1)

• diagnose accordance rate

  Proportion of PET/CT diagnostic reports consistent with pathological results

  2022.1.20-2022.7.30

Secondary Outcomes (5)

• Standardized Uptake Mean (SUVmean)

  2022.1.20-2022.7.30

• Standardized Uptake Maximum (SUVmax)

  2022.1.20-2022.7.30

• Tumor Background Ratio

  2022.1.20-2022.7.30

• Tumor Metabolic Volume (MTV)

  2022.1.20-2022.7.30

• Total Glycolysis (TLG)

  2022.1.20-2022.7.30

Interventions

68Ga-FAPI-04 imaging agent DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Voluntarily participate and sign a written informed consent;
• years old (inclusive) male or female;
• Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc.
• Those who obtained pathological diagnosis results through needle biopsy or surgical resection;
• Have willingness and ability to participate in all research procedures.

You may not qualify if:

• Women who are pregnant or breastfeeding;
• Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients;
• Those who have a history of other malignant tumors in the past;
• Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L;
• Patients with claustrophobia;
• Those who cannot tolerate lying down for 15-30 minutes;
• The researchers believe that it is not suitable to participate in this clinical trial;
• Those who have participated in clinical trials or are participating in other clinical trials within the past month

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue

MeSH Terms

Conditions

Digestive System Diseases

Central Study Contacts

Yufeng Yuan

CONTACT

13995564795; yuanyf1971@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 3, 2022
• Study Start: January 20, 2022
• Primary Completion: July 30, 2022
• Study Completion: October 31, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CN (1)