Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-07 @ 3:00 PM
Study NCT ID:
NCT05923268
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2023-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy
Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Organization:
Study Overview
Official Title:
SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins ([99mTc]Tc-G3-(G3S)3C)
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer
Detailed Description:
Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy).
Phase I. Distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.
Phase I. Distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: