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

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

September 15, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
PET/CTFAPIOral Cancer
Interventions
DRUG

68Ga-DOTA-FAPI

Intravenous access is pre-established. Quality control is carried out to confirm the radiochemical purity of 68Ga-DOTA-FAPI by HPLC. Intravenous administration of 68Ga-DOTA-FAPI according to 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.

DEVICE

PET/CT

Each subject undergoes PET/CT imaging within 20-30 minutes after injection.

DIAGNOSTIC_TEST

Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.

"This observational study evaluates the application of paired FDG and FAPI PET/CT in oral cancer.~1. Baseline phase: All participants undergo baseline FDG and FAPI PET/CT scans.~2. Post-neoadjuvant phase: For patients with resectable locally advanced disease receiving neoadjuvant therapy (as per clinician decision), a second FAPI PET/CT scan is performed after 2 cycles of treatment to assess treatment response.~3. Purpose: To explore the utility of FAPI PET in (a) initial staging, (b) treatment response evaluation, and (c) prognostic value in oral cancer."

Trial Locations (1)

430071

RECRUITING

Zhongnan Hopital of Wuhan University, Wuhan

All Listed Sponsors
lead

Zhongnan Hospital

OTHER