Primary Breast Cancer
Conditions
Keywords
[99mTc]Tc -ZHER2:4107, Breast Cancer, HER2 expression
Brief summary
The study should evaluate the \[99mTc\]Tc -ZHER2:4107 accumulation in primary tumour of breast cancer patients with different HER2 expression
Detailed description
To determine different HER2 expression in primary breast cancer patients before any system or local treatment.
Interventions
DRUGInjection of [99mTc]Tc-ZHER2:4107, SPECT/CT
One single injection of \[99mTc\]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after 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)
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 HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative 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), 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 -ZHER2:4107 uptake in primary breast tumor | 2 hours | SPECT/СT-based \[99mTc\]Tc -ZHER2:4107 uptake in primary breast tumor with different HER2 expression (SUVmax) |
| [99mTc]Tc -ZHER2:4107 background uptake | 2 hours | SPECT-based \[99mTc\]Tc -ZHER2:41 background uptake value (SUVmax) |
| Tumor-to-background ratio | 2 hours | The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc -ZHER2:41 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc -ZHER2:41 uptake coinciding with the regions without pathological findings (SUVmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differentiation of HER2 expression in primary tumors | 2 hours | To evaluate the threshold values of \[99mTc\]Tc -ZHER2:4107 accumulation for differentiation of HER2 expression in primary tumors in breast cancer patients |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORVladimir I Chernov, MD, Prof
Tomsk NRMC
Outcome results
None listed