A Phase 1 interventional study of SPECT in Primary Breast Cancer, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Completed at 1 site in Russia. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Phase 1, Interventional, and Diagnostic
The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
The secondary objective are:
1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples.
Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.
Phase I. Distribution of 99mTc-HE3-G3 in patients with primary breast cancer. The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
The secondary objective are:
1. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:
Methodology:
Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Availability of results from HER2 status previously determined on material from the primary tumor, either
Hematological, liver and renal function test results within the following limits:
Exclusion Criteria:
At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 1000 μg. Subjects withdrawn from the study for any reason will be replaced.
Drug: SPECT
At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 2000 μg. Subjects withdrawn from the study for any reason will be replaced.
Drug: SPECT
At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg. Subjects withdrawn from the study for any reason will be replaced.
Drug: SPECT
One single injection of 99mTc-HE3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.
Gamma camera-based whole-body 99mTc-HE3-G3 uptake value (%)
Whole-body 99mTc-HE3-G3 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-HE3-G3 uptake value in tumor lesions (counts)
99mTc-HE3-G3 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-HE3-G3background uptake value (counts)
Focal uptake of 99mTc-HE3-G3 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-HE3-G3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-HE3-G3 uptake coinciding with the regions without pathological findings (counts)
Time frame: 6 hours
Safety attributable to 99mTc-HE3-G3 injections (physical findings)
The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (% of cases with abnormal findings relative to baseline)
Time frame: 24 hours
Safety attributable to 99mTc-HE3-G3 injections (laboratory tests)
The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)
Time frame: 24 hours
Safety attributable to 99mTc-HE3-G3 injections (incidence and severity of adverse events)
The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the rate of adverse events (%)
Time frame: 24 hours
Safety attributable to 99mTc-HE3-G3 injections (concomitant medication)
The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the rate of administration of concomitant medication (%)
Time frame: 24 hours
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Tomsk National Research Medical Center of the Russian Academy of Sciences