Clinical trial

The Diagnostic Efficiency of 68Ga-FAPI PET/CT in Malignant Tumors

Name
ZNYYHYXK0001
Description
Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.
Trial arms
Trial start
2021-02-23
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
68Ga-FAPI
68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).
Arms:
68Ga-FAPI PET/CT in malignant tumors
Other names:
68Ga-fibroblast activation protein inhibitor
PET/CT
68Ga-FAPI PET/CT scan were performed 20\~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.
Arms:
68Ga-FAPI PET/CT in malignant tumors
Other names:
positron emission tomography/computed tomography
Size
500
Primary endpoint
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors
three years
Eligibility criteria
Inclusion Criteria: Volunteering to participate in clinical trial and sign an informed consent form Patients with suspected or confirmed malignant tumor Exclusion Criteria: Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drug Patients have participated in other clinical trials in the past one month
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Experimental: 68Ga-FAPI PET/CT Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2024-02-02

1 organization

1 product

3 indications

Organization
Zhongnan Hospital
Product
68Ga-FAPI
Indication
PET/CT
Indication
Cancer