An interventional study of 68Ga-FAPI Positron Emission Tomography-Computed Tomography in PDAC, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Diagnostic
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.
151 studies on the registry are indexed under Carcinoma, Ductal; 17 are open to participants now.
This study's planned enrollment of 80 is above the median of 48 across 116 interventional studies indexed under Carcinoma, Ductal.
Browse Carcinoma, Ductal studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Exclusion Criteria:
Patients with suspected pancreatic lesions underwent 68Ga-FAPI PET/CT to distinguish benign and malignant lesions, to evaluate the resectability of lesions and to detect distant metastasis. The clinicians decided the treatment methods based on the results of 68Ga-FAPI PET/CT.
Diagnostic Test: 68Ga-FAPI Positron Emission Tomography-Computed Tomography
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.
Standard 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
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital