Colorectal Cancer Clinical Trial
— FAPIOfficial title:
Head-to-head Comparison of Positron Nuclide Radio-labeled FAPI and 18F-FDG PET/CT in Patients With Malignant Tumors
Verified date | December 2023 |
Source | Guangdong Provincial People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The latest research has found that the use of positron-labeled FAP inhibitors for targeting FAP has achieved very good results in displaying tumor stroma, especially for tumors with poor FDG PET/CT observation, such as liver cancer, renal cancer, and gastric cancer. Although the studies were based on small sample data or case reports, they achieved significantly better results than 18F-FDG [13,15-17]. For patients who meet the inclusion and exclusion criteria, using FAPI PET/CT and FDG PET/CT imaging may have guiding significance for your treatment. If distant metastasis is found, information such as the location, size, and quantity of metastasis can be provided to provide objective imaging information for further treatment; We will promptly provide detailed information to you and your supervising physician, who will guide your personalized treatment. The drugs used have undergone strict quality inspection, and currently, no adverse reactions have been found in multiple medical institutions both domestically and internationally. If you experience any discomfort, new changes in your condition, or any unexpected circumstances during the study period, regardless of whether it is related to the study or not, you should promptly notify your doctor or contact our research leader. He/she will make a judgment and provide appropriate medical treatment. We will provide a certain proportion of compensation for any additional visits and expenses incurred during this examination. The entire research process is under the supervision of relevant departments of Guangdong Provincial People's Hospital. If you encounter any questions during the research process, you can consult the research doctor.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients with high clinical suspicion of malignant tumors; 2. Those who have undergone endoscopic biopsy or puncture biopsy indicating malignant tumors but have not undergone surgery or chemotherapy; 3. Previous history of malignant tumor surgery, suspected of recurrence or distant metastasis; 4. There is a willingness for puncture biopsy or surgery, and there are no contraindications for puncture biopsy or surgery, and there are no contraindications for anesthesia; 5. Sign an informed consent form and undergo a nuclear medicine examination, without any contraindications, with the ability and willingness to participate in the follow-up plan. Exclusion Criteria: 1. Those who cannot tolerate puncture biopsy or surgical contraindications; 2. Those who have undergone radiotherapy and chemotherapy in the past 3 months; 3. Individuals who are allergic to multiple drugs or foods; 4. Those who refuse nuclear medicine examinations; 5. Those who do not agree to sign an informed consent form and are unable or willing to follow up. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Provincial People's Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial People's Hospital |
China,
Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1. — View Citation
Wang L, Tang G, Hu K, Liu X, Zhou W, Li H, Huang S, Han Y, Chen L, Zhong J, Wu H. Comparison of 68Ga-FAPI and 18F-FDG PET/CT in the Evaluation of Advanced Lung Cancer. Radiology. 2022 Apr;303(1):191-199. doi: 10.1148/radiol.211424. Epub 2022 Jan 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SUVmax (Standardized Uptake Value max) | Manual delineation of the area of interest to measure the maximum standard uptake values of the primary lesion and each metastatic lesion | Within 24 hours after the patient's PET/CT scan is completed | |
Secondary | Tumor-to-background ratios | Manually delineate the area of interest to measure the maximum standard uptake value (SUVmax) of the primary lesion and each metastatic lesion, as well as the average standard uptake value (SUVmean) in the liver and ascending aorta. Using the SUVmax/SUVmean ratio | Within 24 hours after the patient's PET/CT scan is completed |
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