TheranosticTrials.org

Clinical Trial · NCT05412446

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

Overview

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.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Phase

Phase 2

Contacts

Vladimir I Chernov, MD, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT05412446

Drug / Compound

ADAPT6

Isotope(s):
Target(s):
  • HER2
Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

  • ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
  • Hemoglobin: \> 80 g/L
  • Bilirubin =\< 2.0 times Upper Limit of Normal
  • Hematological, liver and renal function test results within the following limits:
  • Diagnosis of primary breast cancer with lymph node metastases
  • Serum creatinine: Within Normal Limits
  • White blood cell count: \> 2.0 x 109/L
  • Platelets: \> 50.0 x 109/L
  • 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

Exclusion

  • Any system therapy (chemo-/targeted therapy)