An interventional study of 99mTc-ABH2 in Breast Cancer, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Diagnostic
This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Exclusion Criteria:
The patients will be injected with 5.55 to 7.4 MBq per kilogram body weight of 99mTc-ABH2 in one dose intravenously and undergo SPECT/CT scan 1h to 2h later.
Drug: 99mTc-ABH2
Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.
SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions
Uptake of 99mTc-ABH2 in the lesions will be assessed using SPECT/CT and measured in standardized uptake value (SUV).
Time frame: 1 year
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Peking Union Medical College Hospital