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

ConditionsPET/CTFAPIOral Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorZhongnan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.).

Disqualifiers

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;

Trial population

This study enrolls adults aged 18-70 years with clinically suspected or histopathologically confirmed oral cancer (primary or recurrent). Newly diagnosed patients are scheduled for surgery or neoadjuvant therapy, while recurrent cases require imaging/pathology confirmation. All participants must complete baseline FAPI PET/CT and FDG PET/CT for diagnostic/staging evaluation. Locally advanced patients receiving neoadjuvant therapy will undergo follow-up FAPI PET/CT for therapeutic response assessment. Exclusion criteria include pregnancy, severe allergies to FAPI/FDG, uncontrolled comorbidities, and recent participation in other interventional trials.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 68Ga-DOTA-FAPI

    Drug

    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.

  • PET/CT

    Device

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

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

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: 68Ga-DOTA-FAPI and 18F-FDG PET/CT3 interventions

Trial outcomes

Primary outcomes

1

Diagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer

Comparison of FAPI PET and FDG PET in diagnosing oral cancer, including sensitivity, specificity, accuracy, and TNM staging. Assessments performed at baseline using histopathology and imaging as reference standards.

Time frame
Baseline (at initial diagnosis, prior to treatment)

Secondary outcomes

1

FAPI PET for therapeutic response evaluation

Assessment of FAPI PET parameters for predicting treatment response in patients receiving neoadjuvant therapy. Follow-up FAPI PET performed post-treatment.

Time frame
After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery
2

Prognostic value of FAPI PET parameters in oral cancer

Correlation between FAPI PET parameters and long-term outcomes (e.g., progression-free survival, overall survival).

Time frame
Through study completion, an average of 1 year
3

Correlation between FAPI PET parameters and histopathological biomarkers

Correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak) and histopathological biomarkers of tumor tissue. 1. FAP expression level (H-score; immunohistochemistry) 2. PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay) 3. CD8 expression (H-score; immunohistochemistry) 4. Granzyme B expression (H-score; immunohistochemistry)

Time frame
At baseline and 6 weeks post-FAPI PET scan

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongnan Hospital

Lead sponsor

Source ClinicalTrials.gov
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