RecruitingNCT05030597

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

Sponsor

Zhongnan Hospital

Enrollment

100 participants

Start Date

Sep 15, 2021

Study Type

OBSERVATIONAL

Conditions

PET/CT Oral Cancer FAPI

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

Voluntary participation with signed informed consent;
Aged 18~70 years;
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 Criteria6

Pregnant or breastfeeding women, or women planning pregnancy during the trial period;
Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;
People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;
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.);
Participation in another interventional clinical trial within 30 days prior to enrollment, or planned participation during this study.

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Interventions

DRUG68Ga-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.

DEVICEPET/CT

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

DIAGNOSTIC_TESTParticipants 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.