Primary Breast Cancer
Conditions
Keywords
[99mTc]Tc-DB8, Breast Cancer, Gastrin-releasing peptide receptor expression
Brief summary
The study should evaluate the \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.
Detailed description
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.
Interventions
DRUG[99mTc]Tc-DB8
One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Uppsala University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
Diagnostic SPECT for GRPR expression in primary tumour
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \> 18 years of age 2. Availability of results from estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor 3. 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 4. 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 5. Subject is capable to undergo the diagnostic investigations to be performed in the study 6. Informed consent
Exclusion criteria
1. Any system therapy (chemo-/targeted therapy) 2. Second, non-breast malignancy 3. Active current autoimmune disease or history of autoimmune disease 4. 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 5. Administration of other investigational medicinal product within 30 days of screening 6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [99mTc]Tc-DB8 uptake in primary breast tumor | 2 hours | SPECT/СT-based \[99mTc\]Tc-DB8 uptake in primary breast tumor with positive and negative estrogen receptor expression (SUVmax) |
| [99mTc]Tc-DB8 background uptake value | 2 hours | SPECT/CT-based \[99mTc\]Tc-DB8 background uptake value (SUVmax) |
| Tumor-to-background ratio (SPECT/CT) | 2 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake | 2 hours | To evaluate the threshold values of \[99mTc\]Tc-DB8 accumulation for differentiation of estrogen receptor status in primary tumors in breast cancer patients |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORVladimir I Chernov, MD, Prof
Tomsk NRMC
Outcome results
None listed