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99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes

Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05412446
Collaborator
Uppsala University (Other)
30
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Diagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodesDiagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Primary Tumour and Metastatic Axillary Lymph Nodes Using Technetium-99m-labelled ADAPT6 Molecule-based 99mTc-ADAPT6.
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HER2-positive patients

Maximum 15 evaluable subjects with HER2-positive status in primary tumour before chemo/targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced.

Drug: ADAPT6-SPECT
Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Other Names:
  • Diagnostic ADAPT6-SPECT injection

    		•
    Experimental: HER2-negative patients

    Maximum 15 evaluable subjects with HER2-negative status in primary tumour before chemo/targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced.

    Drug: ADAPT6-SPECT
    Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
    Other Names:
  • Diagnostic ADAPT6-SPECT injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions (SUV) [2 hours]

      SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV

    2. SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes (SUV) [2 hours]

      SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes SUV measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV

    3. Tumor-to-background ratio (SPECT) [2 hours]

      The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)

    4. LN-to-background LN ratio (SPECT) [2 hours]

      The SPECT-based LN-to-background LN ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with LN lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)

    Secondary Outcome Measures

    1. Matching test rate (percentage) [2 hours]

      Comparison of the 99mTc-ADAPT6 accumulation in the primary tumor and metastatic lymph nodes with the results of morphological and immunohistochemical studies.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject is > 18 years of age

    2. Diagnosis of primary breast cancer with lymph node metastases

    3. 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

    4. 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

    1. 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

    2. Subject is capable to undergo the diagnostic investigations to be performed in the study

    3. Informed consent

    Exclusion Criteria:

    1. Any system therapy (chemo-/targeted therapy)

    2. Second, non-breast malignancy

    3. Active current autoimmune disease or history of autoimmune disease

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tomsk NRMC Tomsk Russian Federation

    Sponsors and Collaborators

    • Tomsk National Research Medical Center of the Russian Academy of Sciences
    • Uppsala University

    Investigators

    • Study Director: Vladimir I Chernov, MD, PhD, Caencer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tomsk National Research Medical Center of the Russian Academy of Sciences
    ClinicalTrials.gov Identifier:
    NCT05412446
    Other Study ID Numbers:
    • 99mTc-ADAPT6 in breast cancer
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences
    99mTc-ADAPT6
    Breast Cancer
    metastatic lymph nodes
    HER2 expression
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jun 9, 2022