An observational study in 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 · Observational
The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
The secondary objective is:
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-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
The secondary objective is:
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 16 is below the median of 184 across 2,642 observational 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.
Patients with primary HER2-positive and HER2-negative breast cancer.
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:
11. Informed consent
Exclusion Criteria:
At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 500 µg. Subjects withdrawn from the study for any reason will be replaced.
Diagnostic Test: SPECT
At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 1000 µg. Subjects withdrawn from the study for any reason will be replaced.
Diagnostic Test: SPECT
One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.
Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%)
Whole-body 99mTc-ADAPT6 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-ADAPT6 uptake value in tumor lesions (kcounts)
99mTc-ADAPT6 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in kcounts
Time frame: 6 hours
SPECT-based 99mTc-ADAPT6 background uptake value (kcounts)
Focal uptake of 99mTc-ADAPT6 in the regions without pathological findings will be assessed with SPECT and measured in kcounts
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-ADAPT6 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (kcounts)
Time frame: 6 hours
Safety attributable to 99mTc-ADAPT6 injections (physical findings)
The safety attributable to 99mTc-ADAPT6 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-ADAPT6 injections (laboratory tests)
The safety attributable to 99mTc-ADAPT6 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-ADAPT6 injections (incidence and severity of adverse events)
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of adverse events (%)
Time frame: 24 hours
Safety attributable to 99mTc-ADAPT6 injections (concomitant medication)
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of administration of concomitant medication (%)
Time frame: 24 hours
Plan to share: No
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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