Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy
- Registration Number
- NCT05923268
- Brief Summary
The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer
- Detailed Description
Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy).
Phase I. Distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
-
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
-
Subject is capable to undergo the diagnostic investigations to be performed in the study
-
Informed consent
- 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) 4. 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description The tested injected doses of [99mTc]Tc-G3-(G3S)3C 3000 μg [99mTc]Tc-G3-(G3S)3C At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg. Subjects withdrawn from the study for any reason will be replaced.
- Primary Outcome Measures
Name Time Method SPECT-based [99mTc]Tc-G3-(G3S)3C background uptake value (counts) 6 hours Focal uptake of \[99mTc\]Tc-G3-(G3S)3C in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT) 6 hours The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with the regions without pathological findings (counts)
Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%) 6 hours Whole-body \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts 6 hours SPECT-based \[99mTc\]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) \[99mTc\]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
- Secondary Outcome Measures
Name Time Method Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (vital signs) (% of cases with abnormal findings relative to baseline) 24 hors The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (physical examination) (% of cases with abnormal findings relative to baseline) 24 hours The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% of incidence and severity of adverse events) 24 hours The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the rate of adverse events (%)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (ECG ) (% of cases with abnormal findings relative to baseline) 24 hours The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (laboratory tests) (% of cases with abnormal findings relative to baseline) Time Frame: 24 hours The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% concomitant medication) 24 hours The safety attributable to \[99mTc\]Tc-G3-(G3S)3C injections will be evaluated based on the rate of administration of concomitant medication (%)
Trial Locations
- Locations (1)
Olga
🇷🇺Tomsk, Russian Federation