Breast Cancer Female
Conditions
Keywords
99mTc-ADAPT6, 99mTc-DARPinG3, Breast Cancer, HER2 expression
Brief summary
An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.
Detailed description
The primary objectives are: Compare SPECT/CT imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 in HER2-positive primary tumour of breast cancer patients before system (chemo/targeted) therapy. The secondary objectives are: To compare the SPECT/CT tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.
Interventions
DRUG99mTc-ADAPT6
One single injection of 99mTc-ADAPT6, followed by gamma camera imaging 2 hours after injection.
DRUG99mTc-DARPinG3
One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection.
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Uppsala University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Diagnostic Test: ADAPT6-SPECT and DARPinG3-SPECT Diagnostic SPECT for HER2-positive Breast Cancer 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. Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy); 3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive; 4. Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient; 5. 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 6. 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; 7. Subject is capable to undergo the diagnostic investigations to be performed in the study; 8. Informed consent
Exclusion criteria
1\. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. 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-ADAPT6 uptake (counts)/SUV | 2 hours | SPECT/CT-based 99mTc-ADAPT6 uptake value in primary tumor lesions (counts)/SUV of 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in counts and SUV. |
| 99mTc-ADAPT6 tumor-to-background ratio (SPECT) | 2 hours | The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (counts/SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (counts) |
| 99mTc-DARPinG3 uptake (counts)/SUV | 4 hours | SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor lesions (counts)/SUV of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV |
| 99mTc-DARPinG3 tumor-to-background ratio (SPECT) | 4 hours | The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV) |
| 99mTc-ADAPT6 vs 99mTc-DARPinG3 uptake (counts)/SUV | 2 and 4 hours | Comparison of SPECT/CT-based 99mTc-ADAPT6 versus 99mTc-DARPinG3 uptake value in primary tumor lesions (counts)/SUV of 99mTc-ADAPT6 and 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 and 4 hours after injection and measured in counts and SUV. |
| 99mTc-ADAPT6 vs 99mTc-DARPinG3 tumor-to-background ratio (SPECT) | 2 and 4 hours | Comparison of the value of 99mTc-ADAPT6 versus 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts/SUV) divided by the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 99mTc-ADAPT6 vs immunohistochemical studies (percent) | 2 hours | Sensitivity (%) of the method is assessed by comparing the 99mTc-ADAPT6 accumulation in the primary tumor with the results of immunohistochemical studies |
| 99mTc-DARPinG3 vs immunohistochemical studies (percent) | 4 hours | Sensitivity (%) of the method is assessed by comparing the 99mTc-DARPinG3 accumulation in the primary tumor with the results of immunohistochemical studies |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATOROlga Bragina, MD, Dsc
Tomsk NRMC
Outcome results
None listed