The study should evaluate the \[99mTc\]Tc -ZHER2:4107 accumulation in primary tumour of breast cancer patients with different HER2 expression
To determine different HER2 expression in primary breast cancer patients before any system or local treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
50
One single injection of \[99mTc\]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after injection
Cancer Research Institute of Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Russia
[99mTc]Tc -ZHER2:4107 uptake in primary breast tumor
SPECT/СT-based \[99mTc\]Tc -ZHER2:4107 uptake in primary breast tumor with different HER2 expression (SUVmax)
Time frame: 2 hours
[99mTc]Tc -ZHER2:4107 background uptake
SPECT-based \[99mTc\]Tc -ZHER2:41 background uptake value (SUVmax)
Time frame: 2 hours
Tumor-to-background ratio
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc -ZHER2:41 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc -ZHER2:41 uptake coinciding with the regions without pathological findings (SUVmax)
Time frame: 2 hours
Differentiation of HER2 expression in primary tumors
To evaluate the threshold values of \[99mTc\]Tc -ZHER2:4107 accumulation for differentiation of HER2 expression in primary tumors in breast cancer patients
Time frame: 2 hours
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