A Phase 2 interventional study of [99mTc]Tc-DB8 in Primary Breast Cancer, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Enrolling by invitation 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 2, Interventional, and Diagnostic
The study should evaluate the [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.
The aim of the study is to determine gastrin-releasing peptide receptor expression in primary breast cancer patients with positive and negative estrogen receptor expression before any systemic or local treatment.
Phase II. Assessment of [99mTc]Tc-DB8 accumulation in primary tumors with positive and negative estrogen receptor expression in breast cancer patients.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 9,303 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.
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Hematological, liver and renal function test results within the following limits:
Exclusion Criteria:
Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive estrogen receptor expression.
Drug: [99mTc]Tc-DB8
Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with negative estrogen receptor expression.
Drug: [99mTc]Tc-DB8
One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection
Also known as: Technetium-99m-labelled DB8
[99mTc]Tc-DB8 uptake in primary breast tumor
SPECT/СT-based \[99mTc\]Tc-DB8 uptake in primary breast tumor with positive and negative estrogen receptor expression (SUVmax)
Time frame: 2 hours
[99mTc]Tc-DB8 background uptake value
SPECT/CT-based \[99mTc\]Tc-DB8 background uptake value (SUVmax)
Time frame: 2 hours
Tumor-to-background ratio (SPECT/CT)
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DB8 uptake coinciding with the regions without pathological findings (SUVmax)
Time frame: 2 hours
Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake
To evaluate the threshold values of \[99mTc\]Tc-DB8 accumulation for differentiation of estrogen receptor status in primary tumors in breast cancer patients
Time frame: 2 hours
Plan to share: Yes — Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
Supporting information: Study protocol, Sap, Icf
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Tomsk National Research Medical Center of the Russian Academy of Sciences