HER2 Expression Detection in Breast Cancer Using 99mTc-NM-02

Status Completed

Clinical Trial Summary

A 99mTc-labeled anti-HER2-sdAb (99mTc-NM-02) will be developed for SPECT/CT assessment of HER2 expression in breast cancer patients. Its safety, radiation dosimetry and biodistribution, and the relationship between tumor uptake and HER2 immunohistochemistry results will be investigated.

Clinical Trial Description

To evaluate the safety, dosimetry and efficacy of 99m-Tc labeled anti-HER2 single domain antibody (sdAb) (Product Code Name: 99mTc-NM-02) SPECT/ CT imaging of HER2 expression in Breast Cancer and compare it with the existing gold standard " HER2 expression detection" by biopsy tissue immunohistochemistry (IHC) and/or Fluorescence In Situ Hybridization (FISH) method. It is also to establish a new clinical method of non-invasive HER2 expression detection in breast cancer using 99m-Tc labeled anti-HER2 sdAb ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04040686
Study type	Interventional
Source	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact
Status	Completed
Phase	Early Phase 1
Start date	July 29, 2019
Completion date	March 30, 2022

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