Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3

Tomsk National Research Medical Center of the Russian Academy of Sciences15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer Female

Interventions

99mTc-ADAPT6DRUG

One single injection of 99mTc-ADAPT6, followed by gamma camera imaging 2 hours after injection.

99mTc-DARPinG3DRUG

One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Tomsk NRMC

Tomsk, Russia

Outcomes

Primary Outcomes

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.

Time frame: 2 hours

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)

Time frame: 2 hours

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

Time frame: 4 hours

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)

Time frame: 4 hours

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.

Time frame: 2 and 4 hours

Data from ClinicalTrials.gov

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