[99mTc]Tc-DB8 Accumulation in Primary Tumor in Breast Cancer With Positive and Negative Estrogen Receptor Expression
Enrolling by invitation · Phase 2
Conditions studied: Primary Breast Cancer
In brief
The study should evaluate the \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.
Key facts
- Study ID
- NCT07275463
- Run by
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- People needed
- 40
- Starts
- 2025-10-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Subject is > 18 years of age
- Availability of results from estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor
- Hematological, liver and renal function test results within the following limits:
- White blood cell count: > 2.0 x 109/L
- Hemoglobin: > 80 g/L
- Platelets: > 50.0 x 109/L
- ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
- Bilirubin =< 2.0 times Upper Limit of Normal
- Serum creatinine: Within Normal Limits
- A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
- Subject is capable to undergo the diagnostic investigations to be performed in the study
- Informed consent
You may not qualify if…
- Any system therapy (chemo-/targeted therapy)
- Second, non-breast malignancy
- Active current autoimmune disease or history of autoimmune disease
- Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
- Administration of other investigational medicinal product within 30 days of screening
- Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Where it is running
- Russia Tomsk NRMC — Tomsk, Russia
Full record on ClinicalTrials.gov
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