Tumor
Conditions
Interventions
Gold Standard:The primary lesion and metastatic lesions that are easy to biopsy are based on pathology as the gold standard. Tissue specimens are obtained through biopsy, and the specific type and cha
Index test:The sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of 18F/68Ga-HER2 PET/CT or PET/MR in the diagnosis, staging, early evaluation of
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age= 18 years old; 2) Patients who need to undergo HER2 status assessment, HER2-positive tumor staging, neoadjuvant therapy and other post-treatment efficacy evaluation and prognosis evaluation; 3) Renal function: serum creatinine = 1.5 times the upper limit of normal; 4) The patient has good compliance with the planned examinations, can understand the study process of this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Age< 18 years old; 2) Cardiac ejection fraction <50%; 3) Severe hepatic and renal insufficiency; 4) Pregnant or lactating patients, and patients of childbearing potential who refuse to use adequate contraception during the course of this trial; 5) Uncontrolled severe infection, or other serious concomitant diseases; 6) Patients who are judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Accuracy;Positive predictive value;Negative predictive value; | — |
Secondary
| Measure | Time frame |
|---|---|
| SUVmax before neoadjuvant therapy;SUVmax after neoadjuvant therapy; | — |
Countries
China
Contacts
Public ContactXinming Zhao
The Fourth Hospital of Hebei Medical University
Outcome results
None listed