Clinical trial NCT05376644: Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3
Official title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-ADAPT6 and 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients Before System (Chemo/Targeted) Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: 99mTc-ADAPT6
99mTc-DARPinG3
Breast Cancer
HER2 expression
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2022-05-17
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diagnostic Test: ADAPT6-SPECT and DARPinG3-SPECT Diagnostic SPECT for HER2-positive Breast Cancer primary tumour
Primary purpose: DIAGNOSTIC

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

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.

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.

Eligibility criteria: 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

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Primary outcomes:
measure: 99mTc-ADAPT6 uptake (counts)/SUV
timeFrame: 2 hours
measure: 99mTc-ADAPT6 tumor-to-background ratio (SPECT)
timeFrame: 2 hours
measure: 99mTc-DARPinG3 uptake (counts)/SUV
timeFrame: 4 hours
measure: 99mTc-DARPinG3 tumor-to-background ratio (SPECT)
timeFrame: 4 hours
measure: 99mTc-ADAPT6 vs 99mTc-DARPinG3 uptake (counts)/SUV
timeFrame: 2 and 4 hours
measure: 99mTc-ADAPT6 vs 99mTc-DARPinG3 tumor-to-background ratio (SPECT)
timeFrame: 2 and 4 hours
Secondary outcomes:
measure: 99mTc-ADAPT6 vs immunohistochemical studies (percent)
timeFrame: 2 hours
measure: 99mTc-DARPinG3 vs immunohistochemical studies (percent)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk NRMC
Study officials:
affiliation: Tomsk NRMC
name: Olga Bragina, MD, Dsc
role: PRINCIPAL_INVESTIGATOR
References: