The study should evaluate distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer. The primary objective are: 1. To assess distribution of \[99mTc\]Tc-DARPinEc1-G3C in normal tissues and in tumors over time; 2. To evaluate dosimetry of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients; 3. To obtain initial information concerning safety and tolerability of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients after single intravenous injection: The secondary objective are: 1\. To compare the tumour imaging data with \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients with Triple negative and Luminal subtypes.
Overall goal of the project: To determine EpCam expression in primary breast cancer before any system therapy. Phase I. Distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer before treatment. Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
One single injection of \[99mTc\]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.
Russia Tomsk NRMC
Tomsk, Tomsk Reg, Russia
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
Whole-body \[99mTc\]Tc-DARPinEc1-G3C 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-DARPinEc1-G3C uptake value in tumor lesions (counts)
\[99mTc\]Tc-DARPinEc1-G3C 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-DARPinEc1-G3C background uptake value (counts)
Focal uptake of \[99mTc\]Tc-DARPinEc1-G3C 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-DARPinEc1-G3C uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with the regions without pathological findings (counts)
Time frame: 6 hours
Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline
The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of physical examination (percent of cases with abnormal findings relative to baseline)
Time frame: 48 hours
Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline
The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of vital signs (percent of cases with abnormal findings relative to baseline)
Time frame: 48 hours
Rate of adverse events (percent)
The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent)
Time frame: 48 hours
Rate of administration of concomitant medication (percent)
The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent)
Time frame: 48 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.