Breast Cancer Female Clinical Trial
Official title:
SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-ADAPT6 and 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients Before System (Chemo/Targeted) Therapy.
Verified date | April 2023 |
Source | Tomsk National Research Medical Center of the Russian Academy of Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 21, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | 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 HercepTestâ„¢ 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 - |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Tomsk NRMC | Tomsk |
Lead Sponsor | Collaborator |
---|---|
Tomsk National Research Medical Center of the Russian Academy of Sciences | Uppsala University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 99mTc-ADAPT6 uptake (counts)/SUV | 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. | 2 hours | |
Primary | 99mTc-ADAPT6 tumor-to-background ratio (SPECT) | 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) | 2 hours | |
Primary | 99mTc-DARPinG3 uptake (counts)/SUV | 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 | 4 hours | |
Primary | 99mTc-DARPinG3 tumor-to-background ratio (SPECT) | 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) | 4 hours | |
Primary | 99mTc-ADAPT6 vs 99mTc-DARPinG3 uptake (counts)/SUV | 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. | 2 and 4 hours | |
Primary | 99mTc-ADAPT6 vs 99mTc-DARPinG3 tumor-to-background ratio (SPECT) | 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) | 2 and 4 hours | |
Secondary | 99mTc-ADAPT6 vs immunohistochemical studies (percent) | Sensitivity (%) of the method is assessed by comparing the 99mTc-ADAPT6 accumulation in the primary tumor with the results of immunohistochemical studies | 2 hours | |
Secondary | 99mTc-DARPinG3 vs immunohistochemical studies (percent) | Sensitivity (%) of the method is assessed by comparing the 99mTc-DARPinG3 accumulation in the primary tumor with the results of immunohistochemical studies | 4 hours |
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