Using PET imaging to improve diagnosis and treatment evaluation in oral cancer
Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
This study is testing a new type of imaging to see if it can help doctors better diagnose and treat oral cancer compared to the standard method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhongnan Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05030597 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of PET/CT imaging using the agent 68Ga-FAPI compared to the conventional 18F-FDG in diagnosing and staging oral squamous cell carcinoma. By focusing on cancer-associated fibroblasts and their specific marker, fibroblast activation protein (FAP), the study seeks to enhance the accuracy of tumor delineation and detection of metastases. Participants will undergo paired baseline imaging with both agents to assess their diagnostic value and monitor treatment responses in locally advanced cases receiving neoadjuvant therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with clinically confirmed or highly suspected oral cancer, including those scheduled for surgery or neoadjuvant therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have severe allergies to the imaging agents will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnosis and better treatment strategies for patients with oral cancer.
How similar studies have performed: While the use of PET imaging in cancer diagnosis is established, the specific application of FAP-targeted imaging in oral cancer is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Zhongnan Hopital of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Jiang Yaqun, PhD
- Email: zn004239@whu.edu.cn
- Phone: 0086-027-67812698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.