Status:
COMPLETED
Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborating Sponsors:
Uppsala University
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 en...
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. ...
Eligibility Criteria
Inclusion
- Subject is \> 18 years of age;
- Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);
- 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;
- Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;
- 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
Exclusion
- 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
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Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05376644
Start Date
May 1 2022
End Date
January 21 2023
Last Update
April 25 2023
Active Locations (1)
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1
Tomsk NRMC
Tomsk, Russia, 634005