99mTc-DARPinG3 SPECT/CT for Non-invasive HER2-AX in Breast Cancer With Metastatic Lymph Nodes Before Targeted Therapy

SPECT/CT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Primary Tumour and Metastatic Axillary Lymph Nodes Using Technetium-99m-labelled DARPinG3 Molecule-based.

An open-label, single center study with 99mTc-DARPinG3 SPECT/CT 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-DARPinG3 SPECT/CT and standard histopathology from relevant tumor and lymph node biopsies.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Drug: 99mTc-DARPinG3 SPECT/CT

Detailed Description

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before chemo/targeted therapy.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation
    • Russia Tomsk NRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer female patients

Description

Inclusion Criteria:

• Subject is > 18 years of age
• Diagnosis of primary breast cancer with lymph node metastases
• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPECT/CT-based 99mTc-DARPinG3 uptake in tumor lesions	SPECT/CT-based 99mTc-DARPinG3 uptake value in tumor lesions (counts)/SUV of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions is assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV	4 hours
SPECT/CT-based 99mTc-DARPinG3 uptake value in metastatic lymph nodes	SPECT/CT-based 99mTc-DARPinG3 uptake value in metastatic lymph nodes (counts)/SUV of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions is assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV	4 hours
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/SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)	4 hours
LN-to-background LN ratio (SPECT)	The SPECT-based LN-to-background LN ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with LN lesions (counts/SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphological and immunohistochemical verification of 99mTc-DARPinG3 accumulation	Comparison of the 99mTc-DARPinG3 accumulation in the primary tumor and metastatic lymph nodes with the results of morphological and immunohistochemical studies	4 hours

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Vladimir Chernov, MD, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; HER2; metastatic lymph nodes; 99mTc-DARPinG3
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 99mTc-DARPinG3 breast cancer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No