A 99mTc-labeled anti-HER2-sdAb (99mTc-NM-02) will be developed for SPECT/CT assessment of HER2 expression in breast cancer patients. Its safety, radiation dosimetry and biodistribution, and the relationship between tumor uptake and HER2 immunohistochemistry results will be investigated.
To evaluate the safety, dosimetry and efficacy of 99m-Tc labeled anti-HER2 single domain antibody (sdAb) (Product Code Name: 99mTc-NM-02) SPECT/ CT imaging of HER2 expression in Breast Cancer and compare it with the existing gold standard " HER2 expression detection" by biopsy tissue immunohistochemistry (IHC) and/or Fluorescence In Situ Hybridization (FISH) method. It is also to establish a new clinical method of non-invasive HER2 expression detection in breast cancer using 99m-Tc labeled anti-HER2 sdAb
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
Patient will be injected with microdose (\<100ug) of 99mTc-NM-02 radiotracer
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Visual Assessment of HER2 expression in Breast cancer using 99mTc-NM-02 SPECT/CT Scan
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99m-Tc-NM-02 in breast malignant lesions. A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
Time frame: 1 year
Semiquantitative Assessment of Breast and other Metastatic Lesions in 99mTc-NM-02 SPECT/CT Scan
Each subject will be administered 3-12 MBq/kg of 99mTc-NM-02 and the semiquantitative analysis of the region of interest (ROI) will be performed in breast and other metastatic lesions. Higher level of HER2 expression (Tumor proportion score, TPS), higher ROI in tumor.
Time frame: 1 year
Safety of 99mTc-NM02 through Adverse Event Monitoring
Subjects will be observed for safety after administration of 99mTc-NM-02, and will do follow up at 48h p.i. Subjects will do blood test to observe for abnormalities in clinical parameters and compare to baseline results.
Time frame: 2 days
Safety of 99m-Tc-NM-02 through Adverse Event Monitoring
Subjects will be observed for safety after administration of 99mTc-NM-02, and will do follow up at 7d p.i. Subjects will be contacted by investigator by phone and asked several questions related to subject's health after 99m-Tc-NM-02 injection and concomitant drugs.
Time frame: 7 days
HER2 Expression Heterogeneity
Biopsy tissue sample IHC and FISH HER2 test results from subject's primary tumor will indicate its HER2 expression level, this results will be compared with our radiotracer uptake in the primary tumor and will look for heterogeneity while observing for uptake in other metastatic lesions.
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Time frame: 1 year