Breast Cancer
Conditions
Interventions
Gold Standard:Sentinel lymph node biopsy
Index test:Al18F-HER2-BCH PET/CT targeted imaging
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Age range from 18 to 70 years old, regardless of gender, with an ECOG score of 0 or 1; ? Subjects with high HER2 expression tumors or suspected tumors in breast cancer who plan to receive surgical treatment for breast cancer in the near future (within 2 months); ? Expected survival = 12 weeks; ? According to clinical pathology and immunohistochemical examination, the primary focus was confirmed as HER2 positive breast cancer patients. ? Blood routine and liver and kidney function meet the following standards: Blood routine: WBC = 4.0 × 109L or neutrophils = 1.5 × 109L, PLT = 100 × 109/L, Hb = 90g/L; PT or APTT = 1.5ULN; Liver and kidney function: T-Bil = 1.5 × ULT (upper limit of normal value), ALT/AST = 2.5ULN, ALP = 2.5ULN; BUN = 1.5 × ULT, SCr = 1.5 × ULT; ? Women must use effective contraceptives during the study period and within 6 months after the study (effective contraceptives refer to sterilization, intrauterine hormone devices, condoms, contraceptives/pills, abstinence or partner removal of Vas deferens, etc.); Men should agree to subjects who must use contraception during the study period and within 6 months after the end of the study period; ? Able to understand and voluntarily sign informed consent forms, with good compliance.
Exclusion criteria
Exclusion criteria: ? Severe abnormalities in liver and kidney function; ? Pregnant, pregnant, and lactating women; ? Those who cannot lie flat for half an hour; ? Refusing to join this clinical researcher; ? Suffering from Claustrophobia or other mental diseases; ? Other researchers believe that it is not suitable to participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Targeted imaging results of Al18F-HER2-BCH PET/CT;Sensitivity of Al18F-HER2-BCH PET/CT targeted imaging;Specificity of Al18F-HER2-BCH PET/CT targeted imaging;Accuracy of Al18F-HER2-BCH PET/CT targeted imaging;False negative rate of Al18F-HER2-BCH PET/CT targeted imaging;False positive rate of Al18F-HER2-BCH PET/CT targeted imaging;AUC(Area under the curve);Youden's index; | — |
Countries
China
Contacts
Public ContactLingmi Hou
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed