HER2 Expression Detection and Radionuclide Therapy in Breast Cancer Using 99mTc/188Re Labeled Single Domain Antibody
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
To evaluate the safety, dosimetry and efficacy of 99mTc/188Re labeled anti-HER2-single domain
antibody (Product Code Name: 99mTc-NM-02 and 188Re-NM-02) SPECT/CT imaging of HER2 expression
and radionuclide therapy in Breast Cancer. The SPECT/CT results will compare with the
existing gold standard " HER2 expression detection" by biopsy tissue immunohistochemistry
(IHC) and/or Fluorescence in Situ Hybridization (FISH) method, and 18F-FDG PET/CT imaging. It
also to establish a new theranostic method for non-invasive HER2 expression detection and
radionuclide therapy in breast cancer using 99mTc/188Re labeled anti-HER2 single domain
antibody.
Phase:
Early Phase 1
Details
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine