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68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
Study Purpose
FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
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Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.
Arms
Experimental: 68Ga-FAPI-04 PET/CT
The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later.
Interventions
Drug: - 68Ga-FAPI-04
68Ga-FAPI-04 were injected into the patients before the PET/CT scans
Contact a Trial Team
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International Sites
Status
Recruiting
Address
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing, 100730
Site Contact
Rongxi Wang
[email protected]
+8619800370331
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