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

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Brief Title

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

Official Title

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

Brief Summary

      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.

Study Type

Interventional

Primary Outcome

Sensitivity of 68Ga-DOTA-FAPI PET/CT for diagnosis and staging in oral cancer.

Condition

PET/CT

Intervention

68Ga-DOTA-FAPI

Study Arms / Comparison Groups

 68Ga-DOTA-FAPI and 18F-FDG PET/CT
Description:  Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo 68Ga-DOTA-FAPI and 18F-FDG PET/CT imaging within one week.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

100

Start Date

September 15, 2021

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Volunteered to participate in this study and signed informed consent;

          2. Age range from 18 to 70 years;

          3. Clinically highly suspected oral cancer and recurrence after treatment, obtaining
             pathology results and planning surgery;

          4. Willing and able to follow schedule visits, treatment plans and laboratory tests;

          5. 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:

          1. Female patients who plan to become pregnant within 6 months, or are pregnant or
             breastfeeding;

          2. Those who are allergic to test drugs, allergic constitution, or allergic to multiple
             drugs;

          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. The weight exceeds 100 kg;

          6. Patients with claustrophobia;

          7. Those who cannot tolerate lying supine for 15~30 minutes;

          8. Researchers think it is inappropriate to participate in this clinical trial;

          9. Those who have participated in clinical trials or are participating in other clinical
             trials in the past month.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 0086-027-67812698, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT05030597

Organization ID

PTXM2021021

Responsible Party

Sponsor

Study Sponsor

Zhongnan Hospital

Study Sponsor

, ,

Verification Date

December 2021