The study should evaluate the \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.
The aim of the study is to determine gastrin-releasing peptide receptor expression in primary breast cancer patients with positive and negative estrogen receptor expression before any systemic or local treatment. Phase II. Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumors with positive and negative estrogen receptor expression in breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
40
One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection
Russia Tomsk NRMC
Tomsk, Russia
[99mTc]Tc-DB8 uptake in primary breast tumor
SPECT/СT-based \[99mTc\]Tc-DB8 uptake in primary breast tumor with positive and negative estrogen receptor expression (SUVmax)
Time frame: 2 hours
[99mTc]Tc-DB8 background uptake value
SPECT/CT-based \[99mTc\]Tc-DB8 background uptake value (SUVmax)
Time frame: 2 hours
Tumor-to-background ratio (SPECT/CT)
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DB8 uptake coinciding with the regions without pathological findings (SUVmax)
Time frame: 2 hours
Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake
To evaluate the threshold values of \[99mTc\]Tc-DB8 accumulation for differentiation of estrogen receptor status in primary tumors in breast cancer patients
Time frame: 2 hours
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