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Clinical Trial NCT05030597 (FAPI-OSCC) for PET/CT, FAPI, Oral Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma (FAPI-OSCC) 100
Clinical Trial NCT05030597 (FAPI-OSCC) is an observational study for PET/CT, FAPI, Oral Cancer that is recruiting. It started on 15 September 2021 with plans to enroll 100 participants. Led by Zhongnan Hospital, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 28 May 2025.
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 pr...Show More
Official Title
Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
Conditions
PET/CTFAPIOral CancerPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- FAPI-OSCC
- PTXM2021021
NCT ID Number
Start Date (Actual)
2021-09-15
Last Update Posted
2025-05-28
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
100
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
68Ga-DOTA-FAPI and 18F-FDG 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 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 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. 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. Pu...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Baseline (at initial diagnosis, prior to treatment) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery |
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). | Through study completion, an average of 1 year |
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) | At baseline and 6 weeks post-FAPI PET scan |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.).
- 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.
Zhongnan HospitalStudy Central Contact
Contact: Jiang Yaqun, PhD, 0086-027-67812698, [email protected]
Contact: He Yong, PhD, 0086-027-67812698, [email protected]
1 Study Locations in 1 Countries
Hubei
Zhongnan Hopital of Wuhan University, Wuhan, Hubei, 430071, China
Yaqun Jiang, PhD, MD, Contact, 027-67812837, [email protected]
Yong He, PhD, MD, Contact, 027-67812837, [email protected]
Recruiting