NCT05622240

99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 85 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients. A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed description

99mTc-MIRC213 is an nano affibody probe targeting HER2. The investigators will determine the use of 99mTc-MIRC213 SPECT/CT in the detection of HER2- positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-MIRC213 SPECT/CT in stratifying breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	99mTc-MIRC213	99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans

Timeline

• Start date: 2022-09-07
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-11-18
• Last updated: 2022-11-21

Locations

1 site across 1 country: China