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RECRUITING
NCT05030597

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

Sponsor: Zhongnan Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2021-09-15

Completion Date

2025-12-31

Last Updated

2025-05-28

Healthy Volunteers

No

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.

Locations (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, China