Clinical trial
Fibroblast Activation Protein PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application
Name
MJX
Description
This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is:
Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this.
Investigators will screen suitable participants among patients undergoing routine FDG examination.
* Participants will sign an informed consent form
* Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy
* Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up.
The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test.
Trial arms
Trial start
2022-04-28
Estimated PCD
2023-07-28
Trial end
2027-03-31
Treatment
68Ga-Fibroblast activation protein inhibitor
Fibroblast activation protein (FAP), a type II transmembrane serine protease with dipeptidyl peptidase and endopeptidase activities. FAP is a specific surface marker for activated fibroblasts in the mesenchyme of tumors, which account for 90% of the stroma of epithelial neoplasms. FAP inhibitors (FAPIs) can specifically target and bind to FAP. These inhibitors that are radiolabeled with gallium 68 (68Ga-FAPIs) can be probes for visualization of the FAP tumor stroma. Previous studies have demonstrated that 68Ga-FAPI-04 is not dependent on blood glucose levels, has an equal or better tumor-to-background ratio, and clearly visualizes primary tumors and their metastatic foci. In addition, previous studies on 68Ga-FAPI-04 have focused on PET/CT and the efficacy of PET/MR with FAPI for postoperative evaluation of GI tumors remains to be clarified.
Arms:
68Ga-FAPI PET/MRI scan
Other names:
PET-MRI (SIGNA PET/MR manufactured by GE Healthcare)
Size
60
Primary endpoint
68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG
up to 38 months
Eligibility criteria
Inclusion Criteria:
* 18 years ≤ 75 years of age;
* Patients with clinical suspicion of malignancy;
* No invasive tests or treatments recently;
* Blood routine: leukocyte \> 4×109/L, neutrophil \> 2×10 9/L, hemoglobin \> 90g/L, platelets \> 100×10 9/L;
* Cardiac function: left ventricular ejection fraction \>50%;
* Pulmonary function tests: FEV1 ≥1.2L, FEV1% ≥50% and DLCO ≥50%;
* Liver function: total bilirubin \<1.5 times upper limit of normal (ULN); AST and ALT \<1.5 times ULN;
* Renal function: serum creatinine ≤ 1.5 times ULN, or glomerular filtration rate \> 60 ml/min;
* Participants agreed to participate in this clinical trial and signed an informed consent form;
* Good compliance and commitment to follow the study procedures and to cooperate in the implementation of the full study;
* No birth plans for six months.
Exclusion Criteria:
* Those with severe psychiatric symptoms, or those who are too confused to cooperate with the examination;
* Pregnant and potentially pregnant women, lactating women;
* Those with poor compliance.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-02-21
1 organization
1 product
2 indications
Indication
Malignant TumorsIndication
Positron Emission Tomography