Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma (FAPI-OSCC)

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Zhongnan Hospital
Updated on 23 March 2022
squamous cell carcinoma
primary tumor
positron emission tomography
oral cancer


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. 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.

Condition PET/CT, FAPI, Oral Cancer
Treatment PET/CT, 68Ga-DOTA-FAPI
Clinical Study IdentifierNCT05030597
SponsorZhongnan Hospital
Last Modified on23 March 2022


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Inclusion Criteria

Volunteered to participate in this study and signed informed consent
Age range from 18 to 70 years
Clinically highly suspected oral cancer and recurrence after treatment, obtaining pathology results and planning surgery
Willing and able to follow schedule visits, treatment plans and laboratory tests
The clinical laboratory general biochemical examination (heart, liver, kidney, blood routine) and other indicators are in the normal range or abnormal without clinical significance

Exclusion Criteria

Female patients who plan to become pregnant within 6 months, or are pregnant or breastfeeding
Those who are allergic to test drugs, allergic constitution, or allergic to multiple drugs
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
The weight exceeds 100 kg
Patients with claustrophobia
Those who cannot tolerate lying supine for 15~30 minutes
Researchers think it is inappropriate to participate in this clinical trial
Those who have participated in clinical trials or are participating in other clinical trials in the past month
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