An open-label, single center study with 99mTc-DARPinG3 SPECT/CT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPinG3 SPECT/CT and standard histopathology from relevant tumor and lymph node biopsies.
Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before chemo/targeted therapy.
Study Type
OBSERVATIONAL
Enrollment
24
One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection
Russia Tomsk NRMC
Tomsk, Russia
SPECT/CT-based 99mTc-DARPinG3 uptake in tumor lesions
SPECT/CT-based 99mTc-DARPinG3 uptake value in tumor lesions (counts)/SUV of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions is assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV
Time frame: 4 hours
SPECT/CT-based 99mTc-DARPinG3 uptake value in metastatic lymph nodes
SPECT/CT-based 99mTc-DARPinG3 uptake value in metastatic lymph nodes (counts)/SUV of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions is assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV
Time frame: 4 hours
Tumor-to-background ratio (SPECT)
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts/SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)
Time frame: 4 hours
LN-to-background LN ratio (SPECT)
The SPECT-based LN-to-background LN ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with LN lesions (counts/SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)
Time frame: 4 hours
Morphological and immunohistochemical verification of 99mTc-DARPinG3 accumulation
Comparison of the 99mTc-DARPinG3 accumulation in the primary tumor and metastatic lymph nodes with the results of morphological and immunohistochemical studies
Time frame: 4 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.