Clinical Trial · NCT05030597

Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma

Overview

In this prospective study, the investigators will use integrated PET/CT with the agent 68Ga-FAPI and conventional imaging agent 18F-FDG to explore the application value of FAP-targeted molecular imaging in the diagnosis and staging for oral cancer. This study also aims to explore the application value of FAPI imaging in evaluating treatment response for oral cancer.

Sponsor

Zhongnan Hospital

Contacts

He Yong, PhD (CONTACT)

vincentheyong@163.com

0086-027-67812698

Jiang Yaqun, PhD (CONTACT)

zn004239@whu.edu.cn

0086-027-67812698

He Yong, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT05030597

Drug / Compound

FAPI

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Clinically highly suspected oral cancer and recurrence after treatment (Newly diagnosed patients: Scheduled for surgery or neoadjuvant therapy followed by surgery);
  • Ability to complete baseline and follow-up PET/CT (Follow-up FAPI PET/CT applies only to locally advanced patients undergoing neoadjuvant therapy.).

Exclusion

  • People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;
  • Participation in another interventional clinical trial within 30 days prior to enrollment, or planned participation during this study.
  • Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol/L;
  • Claustrophobia or inability to tolerate PET/CT imaging (Those who cannot tolerate lying supine for 15\~30 minutes.);
  • Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;
  • Pregnant or breastfeeding women, or women planning pregnancy during the trial period;