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

Not Applicable

Recruiting

• Conditions: FAPI; Oral Cancer; PET/CT
• Interventions: Drug: 68Ga-DOTA-FAPI; Device: PET/CT; 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.

• Registration Number: NCT05030597
• Lead Sponsor: Zhongnan Hospital

Brief 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.

Detailed Description

Positron emission tomography (PET) molecular imaging provides a valuable method for the diagnosis, differential diagnosis and staging of various tumors. Cancer associated fibroblasts (CAFs) are the main components of tumor stroma, which are involved in tumor cell proliferation, invasion, metastasis and tumor angiogenesis, and play an important role in the occurrence and development of tumors. Fibroblast activation protein (FAP) is the most potential specific molecular marker of CAF, which is mainly expressed in stromal fibroblasts of epithelial tumors and is a potential molecular target for tumor diagnosis and treatment. Oral cancer is the most common type of malignant head and neck cancer, seriously endangering human health. Accurate delineation of the primary tumor, detection of regional nodal metastases, distant metastases and second primary tumors are important for determining the therapeutic strategy and prognosis of oral cancer. Currently, the molecular imaging agent most commonly used in clinical practice for oral cancer is 18F-fluoro-deoxy-glucose (18F-FDG). However, 18F-FDG exhibits some shortages. Inflammatory lesions and the surrounding normal tissue such as brain, tonsils and salivary glands show high uptake of 18F-FDG, often affecting the judgment of lesions.

Adult patients aged \>18 years with clinically confirmed or highly suspected oral cancer will be enrolled. Participants receive paired baseline FDG and FAPI PET/CT to explore the diagnostic and staging value of FAPI PET in oral cancer. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery to evaluate its application in treatment-response assessment. Ultimately, this study aims to comprehensively evaluate the clinical utility of FAPI PET/CT in oral cancer.

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-01
• Study Start: 2021-09-15
• Status Verified: 2024-07
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Voluntary participation with signed informed consent;
2. Aged 18~70 years;
3. Clinically highly suspected oral cancer and recurrence after treatment (Newly diagnosed patients: Scheduled for surgery or neoadjuvant therapy followed by surgery);
4. Ability to complete baseline and follow-up PET/CT (Follow-up FAPI PET/CT applies only to locally advanced patients undergoing neoadjuvant therapy.).

Exclusion Criteria

1. Pregnant or breastfeeding women, or women planning pregnancy during the trial period;
2. Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;
3. People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;
4. Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol/L;
5. Claustrophobia or inability to tolerate PET/CT imaging (Those who cannot tolerate lying supine for 15~30 minutes.);
6. Participation in another interventional clinical trial within 30 days prior to enrollment, or planned participation during this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
68Ga-DOTA-FAPI and 18F-FDG PET/CT	68Ga-DOTA-FAPI	Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery.
68Ga-DOTA-FAPI and 18F-FDG PET/CT	PET/CT	Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery.
68Ga-DOTA-FAPI and 18F-FDG PET/CT	Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.	Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer	Baseline (at initial diagnosis, prior to treatment)	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.

Secondary Outcome Measures

Name	Time	Method
FAPI PET for therapeutic response evaluation	After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery	Assessment of FAPI PET parameters for predicting treatment response in patients receiving neoadjuvant therapy. Follow-up FAPI PET performed post-treatment.
Prognostic value of FAPI PET parameters in oral cancer	Through study completion, an average of 1 year	Correlation between FAPI PET parameters and long-term outcomes (e.g., progression-free survival, overall survival).
Correlation between FAPI PET parameters and histopathological biomarkers	At baseline and 6 weeks post-FAPI PET scan	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)

Trial Locations

Locations (1)

Zhongnan Hopital of Wuhan University; 🇨🇳 Wuhan, Hubei, China