Head-to-head Comparison of Positron Nuclide Radio-labeled FAPI and 18F-FDG PET/CT in Patients With Malignant Tumors
FAPI
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
December 27, 2023
CompletedStudy Start
First participant enrolled
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJanuary 22, 2024
December 1, 2023
1.6 years
December 8, 2023
January 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Tumor-to-background ratios
Within 24 hours after the patient's PET/CT scan is completed
Study Arms (1)
Positron-labeled FAPI PET/CT
EXPERIMENTALImaging was performed 60 minutes after injection of 5mci Positron-labeled FAPI tracer
Interventions
The same group of patients underwent FAPI PET/CT and FDG PET/CT examinations respectively
Eligibility Criteria
You may qualify if:
- Patients with high clinical suspicion of malignant tumors;
- Those who have undergone endoscopic biopsy or puncture biopsy indicating malignant tumors but have not undergone surgery or chemotherapy;
- Previous history of malignant tumor surgery, suspected of recurrence or distant metastasis;
- 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;
- 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.
You may not qualify if:
- Those who cannot tolerate puncture biopsy or surgical contraindications;
- Those who have undergone radiotherapy and chemotherapy in the past 3 months;
- Individuals who are allergic to multiple drugs or foods;
- Those who refuse nuclear medicine examinations;
- Those who do not agree to sign an informed consent form and are unable or willing to follow up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Related Publications (2)
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.
PMID: 34981976BACKGROUNDPang 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.
PMID: 33258746BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2023
First Posted
December 27, 2023
Study Start
January 11, 2024
Primary Completion
August 31, 2025
Study Completion
September 1, 2025
Last Updated
January 22, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Within 2 years after the completion of the study
- Access Criteria
- Case Record Form and Electronic Collection and Management System
Case Record Form and Electronic Collection and Management System