NCT06194565

99mTc-ABH2 SPECT/CT in Breast Cancer

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.

Detailed description

This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	99mTc-ABH2	Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-12-30
• Completion: 2024-01-30
• First posted: 2024-01-08
• Last updated: 2024-01-08

Locations

1 site across 1 country: China