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

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

Plain Language Summary

Simplified for easier understanding

This Chinese study uses a specialized PET scan targeting a protein called FAP (fibroblast activation protein), which is found in the connective tissue surrounding oral cancer tumors, to see if this imaging approach can better detect and map oral squamous cell carcinoma compared to standard scans. **You may be eligible if...** - You are 18–70 years old - You are highly suspected of having oral cancer, or you have had treatment for oral cancer and there is concern about recurrence - You are scheduled for surgery (or neoadjuvant therapy followed by surgery) - You are able to complete the required PET/CT imaging **You may NOT be eligible if...** - You are pregnant or breastfeeding or planning pregnancy during the trial - You have a known allergy to the imaging agents used (FAPI or FDG) - Your heart, lungs, liver, or kidneys are too weak to tolerate surgery - Your fasting blood sugar is above 11.0 mmol/L before the FDG injection - You have claustrophobia or cannot lie still for 15–30 minutes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, China

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NCT05030597


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