PDAC
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TEST68Ga-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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with suspected pancreatic lesions 2. Signed written consent.
Exclusion criteria
1. pregnancy; 2. breastfeeding; 3. any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Uptake Value (SUV） | through study completion, an average of 0.5 year | Determined and compared the SUV for detected lesions in 68Ga-FAPI |
| The numbers of patients who been changed the treatment methods | through study completion, an average of 0.5 year | Determination the patients numbers who been changed the treatment methods after 68Ga-FAPI PET |
| The numbers of lesions | through study completion, an average of 0.5 year | Determination the lesions numbers were detected by 68Ga-FAPI |
| Progression Free Survival (PFS) | through study completion, an average of 1 year | Determination the progression free survival of included patients |
| Overall Survival (OS) | through study completion, an average of 2 year | Determination the overall survival of included patients |
Countries
China
Contacts
Primary ContactJie Ding, MD.
Backup ContactLi Huo, MD.
Outcome results
None listed