This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients. A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.
99mTc-MIRC213 is an nano affibody probe targeting HER2. The investigators will determine the use of 99mTc-MIRC213 SPECT/CT in the detection of HER2- positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-MIRC213 SPECT/CT in stratifying breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China
RECRUITINGDosimetric distribution of radiopharmaceuticals
Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software
Time frame: 2 months
Standardized uptake value
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.
Time frame: 1 year
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Time frame: 1 year
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