SPECT/CT Imaging of Different Types of HER2 Expression in Breast Cancer Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107
Overview
- Phase
- Phase 2
- Status
- Enrolling By Invitation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- [99mTc]Tc -ZHER2:4107 background uptake
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is \> 18 years of age
- •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
- •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
Exclusion Criteria
- •Any system therapy (chemo-/targeted therapy)
- •Second, non-breast malignancy
- •Active current autoimmune disease or history of autoimmune disease
- •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
- •Administration of other investigational medicinal product within 30 days of screening
- •Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Outcomes
Primary Outcomes
[99mTc]Tc -ZHER2:4107 background uptake
Time Frame: 2 hours
SPECT-based \[99mTc\]Tc -ZHER2:41 background uptake value (SUVmax)
Tumor-to-background ratio
Time Frame: 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)
[99mTc]Tc -ZHER2:4107 uptake in primary breast tumor
Time Frame: 2 hours
SPECT/СT-based \[99mTc\]Tc -ZHER2:4107 uptake in primary breast tumor with different HER2 expression (SUVmax)
Secondary Outcomes
- Differentiation of HER2 expression in primary tumors(2 hours)