The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer
Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy). Phase I. Distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
One single injection of \[99mTc\]Tc-G3-(G3S)3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours
Olga
Tomsk, Russia
Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%)
Whole-body \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
Time frame: 6 hours
SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based \[99mTc\]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Time frame: 6 hours
SPECT-based [99mTc]Tc-G3-(G3S)3C background uptake value (counts)
Focal uptake of \[99mTc\]Tc-G3-(G3S)3C in the regions without pathological findings will be assessed with SPECT and measured in counts
Time frame: 6 hours
Tumor-to-background ratio (SPECT)
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with the regions without pathological findings (counts)
Time frame: 6 hours
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (vital signs) (% of cases with abnormal findings relative to baseline)
The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)
Time frame: 24 hors
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Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (physical examination) (% of cases with abnormal findings relative to baseline)
The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)
Time frame: 24 hours
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (laboratory tests) (% of cases with abnormal findings relative to baseline)
The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)
Time frame: Time Frame: 24 hours
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% of incidence and severity of adverse events)
The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the rate of adverse events (%)
Time frame: 24 hours
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (ECG ) (% of cases with abnormal findings relative to baseline)
The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)
Time frame: 24 hours
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% concomitant medication)
The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the rate of administration of concomitant medication (%)
Time frame: 24 hours