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

  • STATUS
    Recruiting
  • days left to enroll
    54
  • participants needed
    15
  • sponsor
    Tomsk National Research Medical Center of the Russian Academy of Sciences
Updated on 26 May 2022

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 endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.

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.

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.

Details
Condition Breast Cancer Female
Treatment 99mTc-ADAPT6, 99mTc-DARPinG3
Clinical Study IdentifierNCT05376644
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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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