hepatic carcinoma
Conditions
Interventions
Gold Standard:abdominal contrast-enhanced MR.
Index test:68Ga-HXCC PET
Sponsors
Department of Nuclear Medicine, West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1)18 years old =75 years old, regardless of gender, and the ability to provide informed consent and confirm the willingness and ability to comply with all requirements of the program; 2) For HCC patients confirmed by pathology/cytology or clinical diagnosis, the diagnostic criteria refer to the "Primary liver cancer diagnosis and treatment standards" (Ministry of Health 2022 Edition): A. Pathological diagnosis criteria: biopsy or surgical excision of liver lesions or extrahepatic metastases, and histopathological/cytological diagnosis of HCC; B. Clinical diagnostic criteria: a clinical diagnosis of HCC can be established when both (1) + (2) a or (1) + (2) b+ (3) of the following conditions are met: (1) there is evidence of cirrhosis and HBV and/or HCV infection (HBV and/or HCV antigen positive); (2) Typical imaging features of HCC: simultaneous multi-row CT scan and/or dynamic contra-enhanced MRI showed rapid heterogeneous vascular enhancement in the arterial phase and rapid elution in the venous or delayed phase. a : HCC can be diagnosed if the diameter of the liver mass is =2cm and one of the CT and MRI imaging tests shows that the liver mass has the above characteristics of liver cancer. b :If the diameter of the liver mass is 1 ~ 2cm, both CT and MRI imaging tests need to show that the liver mass has the above characteristics of liver cancer before HCC can be diagnosed, so as to enhance the specificity of diagnosis. (3) Serum AFP=400µg/L for 1 month or =200µg/L for 2 months, and can rule out other causes of AFP increase, including pregnancy, embryonic tumor of the germ line, active liver disease 3) ECOG physical status score of 0 or 1; 4) expected survival time =12 weeks; 5) during the screening period, patients must have abdominal dynamic enhancement within 2 weeks of our hospital (contrast agent: MRI (and/or enhanced CT) with at least one target lesion measured according to RECIST1.1 criteria (maximum diameter of non-lymph node lesion =10mm, short diameter of lymph node lesion =15mm); 6) liver function status Child-Pugh A grade or grade B score =7. The criteria for Child-Pugh classification of liver function:; 7) patients must have adequate blood and organ function, that is, meet the following criteria: ? Routine blood tests (no blood transfusion within 14 days prior to screening, no G-CSF, no drug correction) a. White blood cell count >3.0 (10^9/L) b. Absolute neutrophil count =1.5 (10^9/L) c. Platelet =75 (10^9/L) d. Hemoglobin =90 (g/L) ? Biochemical examination: (no albumin infusion within 14 days) 10e. Serum creatinine 60mL/minf.ALT and AST=2.5×ULNg. Serum albumin >30 (g/L) h. Serum total bilirubin <1.5×ULNi. Prothrombin time (PT) -International Standardized Ratio (INR) =2.3 or prothrombin (PT) exceeding the normal control range =6 seconds.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Individuals who meet any of the following criteria will be excluded from this study: 1) prior history of other malignant tumors; 2) bleeding tendency and history of thrombosis, which includes a. any CTCAE2 bleeding event within 2 months prior to screening, or CTCAE3 or above bleeding event within 3 months prior to screening; b. a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 6 months prior to screening. For example: imaging examination indicates the presence of severe esophagofundus varices, esophageal varices with bleeding risk, locally active ulcer lesions, stool occult blood ++ or more; c. active bleeding or abnormal coagulation function (PT>16s, APTT>43s, TT>21s, INR=2.3), has bleeding tendency, or is receiving thrombolytic or anticoagulant therapy; d. patients need anticoagulant therapy with drugs such as warfarin or heparin; e. patients require long-term antiplatelet therapy (e.g. Aspirin =300mg/ day, clopidogrel =75mg/ day); f. thrombotic or embolic events within the past 6 months, such as: cerebrovascular accident (including transient ischemic attack), pulmonary embolism; 3) the patient has a known or suspected history of = grade 3 renal and urinary diseases (such as urinary incontinence, nephrostomy, and hydronephrosis); 4) Patients with spinal cord compression, imminent spinal cord compression, or brain parenchymal metastasis. 5) severe or unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident, including transient ischemic attack), or clinically significant ventricular arrhythmias within the first 6 months of enrollment; 6) have a history of epilepsy or known conditions that may induce epilepsy (including but not limited to previous stroke, transient ischemic attack, loss of consciousness within 1 year before enrollment, and cerebral arteriovenous malformation; or intracranial masses, such as schwannomas and meningiomas, that cause edema or placeholder; 7) other laboratory abnormalities: hyponatremia (sodium <130mmol/L); baseline serum potassium <3.5mmol/L (before entering the study, potassium supplementation could be used to restore serum potassium above this level); 8) a history of active human immunodeficiency virus infection or serum anti-HIV positivity; 9) Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 28 days prior to enrollment; 10) have used other investigational drugs within 4 weeks before the start of study treatment or plan to receive other investigational drugs during the study; 11) Known history of allergy, hypersensitivity or intolerance to radiopharmaceuticals; 12) The subject has a pregnant partner or is fertile and is unwilling to take precautions to prevent possible harm to the fetus or to prevent pregnancy during study treatment and within 90 days after ending study administration; 13) claustrophobic patients and those who, for various reasons, are unable to lie still to ensure the completion of the examination; 14) The investigator believes that the subject may have any medical condition or other condition that makes him or her unfit to participate in the study, that interferes with the availability of reliable data, or that prevents the purpose of the study or the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity ;Positive predicative value;Negative predictive value; | — |
Countries
China
Contacts
Public ContactLin Li
West China Hospital, Sichuan University
Outcome results
None listed