Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitutes a major proportion of cells within the tumor microenvironment, especially in primary pancreatic ductal carcinoma (PDAC). In this prospective study, we aimed to evaluate the performance and value of 68Ga-FAPI-04 PET/CT in the patients with PDAC.
With an incidence rate of 10 cases per 100,000 people per year, cancer of the pancreas is the third most common malignancy of the gastrointestinal tract. The overall survival for patients with pancreatic cancer is very poor, with a 5-year survival of 1% to 4%. Successful therapy depends on early diagnosis. The discrimination between benign and malignancies of the pancreas and the assessment of local resectability and distant metastases of the pancreatic cancer remains challenging with different imaging modalities such as ultrasound (US), endoscopic US (EUS), multidetector row computed tomography (MDCT), magnetic resonance imaging (MRI), and 18F-FDG positron emission tomography (PET). PDAC is characterized by a distinct and exuberant desmoplastic stroma, with stromal components outnumbering the pancreatic cancer cells. In PDAC, more than 90% of the tumour volume consists of cancer-associated fibroblasts (CAF). Fibroblast activation protein (FAP) is highly and selectively expressed in CAFs but is weakly expressed or not detected in normal tissues. The aim of this study was to evaluate the impact of FAPI-PET/CT on the clinical management of patients with suspected pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
The patients with suspected pancreatic lesions were included. They underwent 68Ga-FAPI PET/CT to distinguish benign and malignant lesions, to evaluate the resectability of lesions and to detect distant metastasis. The treatment methods were decided according to the results of 68Ga-FAPI PET/CT.
Peking Union Medical College Hospita
Beijing, Beijing Municipality, China
RECRUITINGStandard Uptake Value (SUV）
Determined and compared the SUV for detected lesions in 68Ga-FAPI
Time frame: through study completion, an average of 0.5 year
The numbers of patients who been changed the treatment methods
Determination the patients numbers who been changed the treatment methods after 68Ga-FAPI PET
Time frame: through study completion, an average of 0.5 year
The numbers of lesions
Determination the lesions numbers were detected by 68Ga-FAPI
Time frame: through study completion, an average of 0.5 year
Progression Free Survival (PFS)
Determination the progression free survival of included patients
Time frame: through study completion, an average of 1 year
Overall Survival (OS)
Determination the overall survival of included patients
Time frame: through study completion, an average of 2 year
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